Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

All Conditions

Musculoskeletal Diseases

Prostatic Neoplasms

Bone Diseases

Genital Neoplasms, Male

Urogenital Neoplasms

Genital Diseases

Genital Diseases, Male

Urogenital Diseases

Prostatic Diseases

Male Urogenital Diseases

Whole body MRI with diffusion-weighted imaging (DWI)

WB-MRI

In prostate cancer bone is the most common site for cancer spread, causing pain, fractures, nerve compression and death.

New therapies are available for treating bone disease from cancer and this means that by maintaining patients on drugs that are effective and switching patients to other drugs when current treatment becomes ineffective, patients can be maintained 'better for longer'. However, to do this, it is necessary to accurately tell whether a given treatment is working or not.

In this study, the investigators will perform whole body MRI scans, which include a special scan called diffusion-weighted MRI (DWI MRI) that can provide more information about the participants extent of disease. The investigators aim to show that this test is better than the standard tests of CT and bone scan currently used in the NHS to monitor bone disease. The information from this study will be used to test a special software so that the test may more widely benefit patients across the NHS in the future.

In patients with prostate cancer the current methods to assess treatment response of bone disease such as computer tomography (CT) and bone scan (BS)are unreliable, insensitive to bone disease and have limited criteria to assess disease response confined to bones. Blood tests are inaccurate although some newer tests (e.g. circulating tumour cells tests) show promise but are still under investigation and nuclear medicine investigations such as PET/CT imaging have higher sensitivity, meaning they can detect more sites of disease who are indeed disease than CT or BS but they are more costly and less widely available compared with MRI within the NHS.

For this study the Whole body MRI (WB-MRI) includes a measurement called diffusion-weighted imaging (DWI) which is relatively new and has a high sensitivity for bone metastases. This technique can be used to measure total bone disease volume (TDV) and the disease apparent diffusion coefficient (ADC) which reflects the tumour tissue cell density. Previous studies have shown good reproducibility of both these measurements and a significant increase in the mean tumour ADC is observed in patients who are responding to effective treatment.

However WB-MRI application across the NHS is ad-hoc, CT and BS techniques are entrenched within clinical practice despite their known limitations. Another factor that limits wider adoption of WB-MRI is the lack of sophisticated analysis software to enable disease across the body to be quickly evaluated.

This multi-centre imaging study will provide the opportunity to evaluate the performance of WB-MRI with a novel software diagnostics for evaluating the treatment response of advanced prostate cancer patients.

This prototype can used to evaluate WB-MRI data from different scanners and address a current major unmet need for the treatment and follow-up of patients with bone disease from cancers, so that the test may more widely benefit patients across the NHS in the future.

Male patients with advanced prostate cancer

Whole Body Magnetic Resonance Imaging Study

Fully anonymised trial data will be made available

Explore histogram parameters of ADC in responders and non-responders to treatment.

Explore histogram parameters of TDV in responders and non-responders to treatment.

Explore histogram parameters of fat fractions in responders and non-responders to treatment.

Assess the cost and cost-effectiveness to the NHS of replacing the standard practice conventional tests CT and BS with WB-MRI-derived TDV and ADC measurements for disease management in patients with prostate bone disease using the advanced computer diagnostics software in development using QALYs and obtained from survival data and health-related quality of life.

To establish the diagnostic performance of whole body MRI (WB MRI) using total bone disease volume (TDV) and disease apparent diffusion coefficient (ADC) at Cycle 3 (within 2 weeks before treatment on C4 Day1, each cycle being 28 days or 21 days depending on the type of standard therapy) using new software diagnostics for assessing treatment response to standard therapy (taxane chemotherapy or AR targeted agents)) in patients with bone predominant metastatic disease in prostate cancer using a construct reference standard.

Compare the diagnostic performance of WB-MRI using TDV and ADC at Cycle 3 (within 2 weeks before treatment on C4 Day1, each cycle being 28 or 21 days depending on the type of standard therapy) with the diagnostic performance of standard imaging CT and BS (when available).

Determine the time to progression of responders and non-responders to therapy as defined by WB MRI, versus CT and BS.

Assess the intra-observer and inter-observer agreement of the apparent diffusion coefficient (ADC) and total diffusion volume (TDV) of bone disease assessed by WB-MRI.

Determine the cost-effectiveness of replacing CT and BS with WB-MRI derived TDV and ADC measurements for disease management in patients with prostate bone disease using QALYs.

National Institute for Health Research, United Kingdom

Institute of Cancer Research, United Kingdom

Royal Marsden NHS Foundation Trust

Heart and Blood Diseases

Blood and Lymph Conditions

Immune System Diseases

Rare Diseases

Multiple Myeloma

Neoplasms, Plasma Cell

Neoplasms by Histologic Type

Hemostatic Disorders

Blood Coagulation Disorders

Vascular Diseases

Paraproteinemias

Blood Protein Disorders

Hematologic Diseases

Hemorrhagic Disorders

Lymphoproliferative Disorders

Immunoproliferative Disorders

All Drugs and Chemicals

Bone Density Conservation Agents

Antibodies

Immunoglobulins

Zoledronic Acid

BHQ880 3-40 mg/kg in combination with zoledronic acid 4 mg on day 1 of a 28-day cycle.

BHQ880

Zoledronic acid

Novartis Pharmaceuticals

This study has two portions, a phase I portion and a phase II portion. The purpose of the phase I portion is to assess the maximum-tolerated dose (MTD) and to characterize dose limiting toxicity (DLT) of escalating doses of BHQ880 (up to a maximum dose of 20 mg/kg) in combination with standard chemotherapy and zoledronic acid in relapsed or refractory multiple myeloma patients.

The phase II portion of the study will also be conducted in relapsed or refractory multiple myeloma patients. Patients will be treated with various doses of BHQ880 or placebo in combination standard chemotherapy. In the phase II portion of the study zoledronic acid will be added after the first 28 days of therapy with BHQ880 or placebo and standard chemotherapy. This will allow any BHQ880-related changes in bone biomarkers to be detected in a zoledronic acid-free environment. The purpose of the phase II portion of the study, is to determine one or more doses of BHQ880 for further development based on dose-efficacy modeling. Efficacy is defined as time to first skeletal-related event and change in bone markers for bone resorption and formation relative to placebo. A skeletal-related event is defined as:

* Pathologic fracture
* Spinal cord compression
* Requirement for either radiation or surgery to bone due to:

  * Pain
  * Prevention of imminent fracture
  * Stabilization of a fracture Biomarker and imaging endpoints will be assessed in both phases of the study. The pharmacodynamic effects of BHQ880 will be assessed by measuring biochemical markers of bone formation, resorption, and metabolism in serum and urine. Charges in serum DKK1 levels will be characterized. The size and number of lytic bone lesions as measured by bone survey (X-ray) or MRI will be assessed. In addition, bone mineral density (BMD) will be measured by DEXA scan and at selected sites with QCT scans.

The study was originally planned to have two phases. Phase II, the dose expansion phase, was not conducted.

A Study to Assess BHQ880 in Combination With Zoledronic Acid in Relapsed or Refractory Myeloma Patients

A Phase Ib/II Multicenter Dose-determination Study, With an Adaptive, Randomized, Placebo-controlled, Double-blind Phase II, Using Various Repeated IV Doses of BHQ880 in Combination With Zoledronic Acid in Relapsed or Refractory Myeloma Patients With Prior Skeletal-related Event

Cabozantinib

Andrew Yee, MD

This research study is a Phase I clinical trial. Phase I clinical trials test the safety of an investigational drug. Phase I studies also try to define the appropriate dose of the investigational drug to use for further studies. "Investigational" means that the drug is still being studied and that research doctors are trying to find out more about it. It also means the FDA has not approved the drug for your type of cancer.

Cabozantanib (XL184) is a new drug that is being developed to treat cancer. The study drug cabozantinib works by inhibiting several different proteins which are believed to be involved in multiple myeloma growth, its ability to spread, and its ability to form new blood vessels. This drug has been used in other research studies and information from those other research studies suggests that this drug may help to slow or stop disease growth to bones and prevent cancer growth.

In this research study, we are looking to see how effective cabozantanib is in slowing or stopping disease growth to the bones as well as preventing your cancer from worsening. We are also looking for the highest dose of cabozantinib that can be given safely to patients who have multiple myeloma with bone disease.

Since we are looking for the highest dose of the study drug that can be administered safely without severe or unmanageable side effects in participants that have multiple myeloma, not everyone who participates in this research study will receive the same dose of study drug. The dose you get will depend on the number of participants who have been enrolled in the study before you and how well they have tolerated their doses.

The study drug, cabozantinib, comes in the form of tablets which you will take by mouth. You will take your dose of cabozantinib once a day during each 28 day cycle.

Detailed instructions on how to take the study drug and which foods and drinks you will be prohibited from taking during the research study can be found in your study drug diary.

During Cycle 1, you will come into the clinic weekly (Day 1, 8, 15 and 22). For all other cycles, you will come into the clinic on Day 1 and 15.

A visit will be scheduled 30 days after you have finished or stopped taking the study drug so your doctor will be able to check your well being.

XL184 For Relapsed/Refractory Multiple Myeloma (MM) With Bone Disease

Dose Finding Pilot Study of Cabozantinib (XL184) Administered Orally as Monotherapy for the Treatment of Patients With Relapsed or Relapsed/Refractory Multiple Myeloma With Bone Disease

To determine the safety of cabozantinib in patients with multiple myeloma with bone disease

Changes in biochemical markers of bone turnover, including serum bone specific alkaline phosphatase, osteocalcin, sclerostin, P1nP (procollagen type 1N propeptide) and urine N-telopeptide before treatment and end of cycle 2

To evaluate the effect of cabozantinib on bone disease as assessed by post-treatment changes on whole body FDG-PET/CT scan before treatment and end of cycle 2

Objective response according to the International Myeloma Working Group Uniform Response Criteria (IMWG)

Pain will be assessed using the Pain Assessment Tool included in the appendix. The questionnaire will be administered at screening, day 1 of each cycle and end of treatment

Massachusetts General Hospital

Principal Investigator

Symptoms and General Pathology

Behaviors and Mental Disorders

Pain

Quality of Life

Supervised exercise combined with home based exercise and physical activity

Usual care consisting of advice regarding exercise, physical activity, person lifting and moving.

8 supervised in-hospital training sessions in a period of 10 weeks. On a general level, the intervention will follow the Danish physical activity guidelines for elderly \>65 years (Sundhedsstyrelsen 2011, see link) and consist of strength exercise, aerobic exercise and physical activity.

Bone involvement will taken into consideration in all parts of the exercise program by excluding and including specific exercises and mode of exercise according to location and extent of bone involvement (Galvão 2011; Cormie 2013)

Exercise

Rikke F Larsen, Ph.d.

Niels Abildgaard, Professor

The overall aim is to examine whether early initiated, individualized exercise training in patients newly diagnosed with multiple myeloma, irrespective of age and current performance status, will be beneficial for the patients´physical function, level of physical activity and quality of life, pain and bone disease.

The investigators will examine the effect of supervised in-hospital exercise training sessions combined with home-based exercise training, initiated at time of diagnosis. The outcomes of interest are physical function, level of physical activity, QOL, pain and bone disease.

Furthermore, to describe the disease in patients with newly diagnosed MM in relation to physical function, level of physical activity, QOL, pain and bone condition at time of diagnosis.

The investigators hypotheses are:

* Individualized exercise starting at time of diagnosis will have positive effects on physical function, physical activity, QOL and pain.
* Individualized exercise starting at time of diagnosis will have positive effects on bone disease (bone markers), bone mineral density (BMD) and lean body mass.
* A higher level of physical function is associated with a higher level of physical activity, less pain, better QOL, and higher BMD and lean body mass.

Background Physical exercise for haematological patients is a relevant complementary treatment, including in patients with multiple myeloma (MM) (Jones 2013). In hematological cancer, exercise is feasible, safe and beneficial in numerous aspects (aerobic capacity, muscle strength, quality of life (QOL), fatigue, psychosocial wellbeing, treatment-related symptoms and body composition, before, during and after stem cell transplantation (Persoon 2013; Haren 2013). Still the evidence for the value of exercise in hematological diseases is sparse, in general and to specific diagnoses (Jones 2013; Fong 2014; Liu 2009). Patients with MM may differ from other hematological diseases, by poorer functional status due to skeletal related pain, affected QOL and immune function, but also in return to work and in risk of disability pension, and furthermore physical performance and the time of being physical active is diminished throughout the treatment course and patients do not meet physical activity guidelines (Coleman 2004; Jones 2004; Craike 2013). Hence, there is a need to examine the effect of exercise to be able to give evidence based recommendations on exercise in MM patients.

In Denmark, 320 patients are diagnosed with MM annually. The median age at diagnosis is 68-71 years, and the incidence is increasing with age. The prevalence increases due to the aging population and improved survival because of improvement in medical treatment (Kyle 2007; Sihori 2006 \& 2004; Alexander 2007; Kumar 2008 \& 2014). Typically, the patient presents with bone pain, anaemia, renal failure, recurrent infections, or for some patients it is detected by chance through screening of blood or urine. Bone pain is caused by osteolytic destructions which also may lead to pathological fractures.

When diagnosed, most patients (80%) will have symptomatic disease and will need start treatment. The medical treatment for MM has two aims. Firstly, anti-myeloma systemic therapy aims at reducing tumor burden and to prolong disease free survival, and overall survival, and secondly, supportive care aims at preventing serious morbidity from disease complications. Younger patients (\<65-70 year) are treated with high dose chemotherapy with stem cell support (HDT). Elderly patients receive less intensive, yet still effective treatments that include novel agents (bortezomib, thalidomide). Painful bone lytic lesions may be treated with radiation therapy. Patients receive i.v. bisphosphonates to reduce the risk of progressive bone disease and fractures (Rosen 2003; Morgan 2011).

Patients with MM (receiving HDT) perceive different symptoms (sleep and mood disturbances, diminished functional performance, pain, shortness of breath, distress, sadness and difficulty paying attention. Symptoms are interrelated and a vicious circle may be present (Coleman 2011; Anderson 2007).

Literature review: Exercise in patients with MM Only 3 RCT studies (Coleman 2003 \& 2008 \& 2012) and 1 single arm pilot study (Groeneveldt 2013) regarding the effect of exercise in patients with MM have been identified. Coleman investigated patients undergoing tandem autologous peripheral blood stem cell transplantation with no risk of fracture, while Groeneveldt investigated MM survivors. All the exercise programs were individualized and home-based, although one study also included weekly supervised training the first three months and monthly the following 3 months. The exercise programs, all compromising stretching, aerobic training and strength resistance training, had a duration of 6 months, and 3 of them started during induction and HDT. The controls were advised to walk 20 minutes 3 times a week.

The single arm pilot study in MM survivors showed significant positive changes in QOL, fatigue and muscle strength, but not in aerobic fitness. Positive, although not significant, changes were seen regarding anxiety/depression. In the studies of Coleman et al. there was a trend towards less decline in aerobic capacity/physical performance in the exercise group compared to the control group. Lean body weight (per month) were significantly increased among those exercising compared to controls. Over the 6 months period strength and lean body weight increased and they perceived less fatigue, better mood and more night time sleep than the controls. Trends of physiologic benefits regarding stem cell collection and transfusions during transplantation were shown.

One Coleman study showed statistical significant changes during the treatment course; decline in physical performance, increase in perceived fatigue, and negative effect on the night sleep, both in the exercise group or the control group. There was no statistical or clinical significant differences in any of the investigated outcomes between the exercise group and the control group at all test times prior to chemotherapy, 10-12 weeks later and 15-16 weeks after stem cell collection. The lack of significant results can be due to poor compliance (based on self-reported activity summary with no results reported in the paper), no structured supervision throughout the exercise intervention and perhaps inadequate intensity in relation to an effect in aerobic capacity. Moreover, the Arkansas anti-myeloma Total Therapy Program is a highly intensive chemotherapy that is not comparable with the induction regimens that are used in Denmark. This highly intensive treatment may very well counteract the benefits of physical training. However, it is noteworthy, that the exercise group had a better physical performance than the control group, although not significant. Importantly, the exercise programs were feasible, acceptable and safe. The performed studies have different shortcomings, such as small study populations, lack of control group, lack of supervised training, no description of whether the assessor was blinded, and inadequate description of the intervention.

In summary, exercise is found to be safe and feasible in patients with MM during induction and HDT, and after discharge. There is a gap in the literature concerning elderly patients with MM and in general in patients treated with less intensive regimens than HDT.

The effect of exercise on physical function needs further examination, especially because the broad group of patients with MM also compromises elderly patients, making exercise even more relevant as a complementary treatment early in the disease course in order to maintain physical function. Because of the nature of the disease involving the bones, it is believed that exercise may be beneficial for maintaining MM patients´ both regarding physical function and bone loss, as in the older population (Chin 2008) and in patients with osteoporosis (Hagen 2011; Howe 2011) or as found in the encouraging results regarding bone health among cancer survivors (Winters-Stone 2010). The literature suggests that combined training is beneficial in order to maintain or increase BMD and lean body mass among patients with prostate cancer or breast cancer (Bolam 2012; Cormie 2014), among post menopausal women (Martyn-St James 2008 \& 2009; Palombaro 2006) and among elderly (Gómez-Cabello 2012). Change in bone markers as an effect of exercise have also been investigated, although in different exercise protocols. The results from healthy women and men are promising. Bone formation markers are significantly increased, without significant changes in bone resorption markers (Shibata 2003; Karabulut 2011). OQL, in a disease specific perspective, needs attention since exercise can improve QOL (Persoon 2013; Haren 2013; Mishra 2012 \& 2012), and since bone pain is a major problem in patients with MM, it is relevant to investigate pain as a separate outcome. It has been demonstrated, that breast cancer survivors meeting physical activity guidelines are significant less likely to report above-average pain than breast cancer survivors not meeting physical activity guidelines, and those who always have been physically active report less pain than inactive women (Forsythe 2013). Griffith (2009) have found, that cancer patients report a lower pain level, if they become more physically active (adjusted for age, cancer diagnosis, pretest pain, pretest physical activity/physical functioning), but Forsythe (2013) have demonstrated unchanged pain level despite increase in physical activity. These results make it even more important to investigate pain in the investigators set up. Physical functioning will have impact on the level of physical activity, which has importance in a long term perspective, but to the investigators knowledge the level of physical activity has not been investigated in patients with MM neither in a prospective design nor with objective measurements.

Recruitment All patients with newly diagnosed MM at Roskilde Hospital and Odense University Hospital will be screened for eligibility on the basis of inclusion and exclusion criteria, at their first appointment with the physician (hematologist) at time of diagnosis.

If eligible, the physician will both briefly inform the patient about the project, and give the written participation information. Before the next consultation (typically after 2-3 days), the investigator will call the patient with further information and address any questions the patient may have regarding the project before written informed consent is obtained.If not eligible or the patient does not want to participate, the patient will be registered only by the reason for exclusion.

Design After inclusion the patients will be randomized 1:1 into an intervention group or control group. The participants will be block randomized and stratified to treatment (planned HDT versus (vs.) non-intensive treatment), performance status (PFS 0-1 vs. PFS≥2) (Oken 1982), and study site (Roskilde vs. Odense). The intervention will start at day 8 (in the 2nd week) after start of treatment unless safety reasons make it necessary to postpone start of exercise. The measurements at all time points will be conducted by experienced, educated investigators (physiotherapists). Measurements will preferably be conducted by the same physiotherapist at each site.

Power calculation The number of patients to be included has been determined by a power calculation, with a significance level, α = 0.05 and 80% power, β = 0.20 and a minimum clinical difference of mean(SD) 7 kg(13.1) in the knee extensor strength (Groeneveldt 2013), which is the primary outcome (corresponding to an increase of approximately 23 %). The number of patients needed, can be estimated to 44 patients in each group (intervention and control).

Statistical analysis It will be tested whether data follow a normal distribution.The following description is based on the assumption that data is normally distributed. For continuous data in an interval scale, mean(sd) will be used and for data in an ordinal scale, median(range) and quartiles will be used to describe data. Differences within group between test times and between groups at all test times will be examined by t-test. The significance level is set to p\<0,05. The analysis will be conducted in accordance with ITT.

To test the investigators hypothesis on the primary outcome (knee extensor strength), t-test will be used and the standard error of the mean difference will be calculated. A mean difference of 7 kg is considered clinical significant, and if this is obtained H0 can be rejected.

To investigate associations between physical function and physical activity, QOL, pain, lean body mass, BMD, and bone markers, scatter plots will be used. If linear correlations exist, the correlations coefficients will be calculated. The correlation will be tested with Fisher´s z transformation and 95%CI will be formed.

Exercise in Patients With Multiple Myeloma

Early Initiated Individualized Physical Training in Newly Diagnosed Multiple Myeloma Patients; Effects on Physical Function, Physical Activity, Quality of Life, Pain, and Bone Disease.

The European Organization for Research and Treatment of Cancer Quality of Life Questionnaire - Core Questionnaire (EORTC QLQ-C30) and The European Organization for Research and Treatment of Cancer Quality of Life Questionnaire - Multiple Myeloma Module (EORTC QLQ-MY20) (68)

Measured objectively by accelerometer (ActivPal) in periods of 5 days

Osteoblast and osteoclast activity measured by dynamic markers (PINP and CTX-1) of bone metabolism in serum.

Odense University Hospital

Region Zealand

Region of Southern Denmark

Association of Danish Physiotherapists

Zealand University Hospital

Wounds and Injuries

Fractures, Bone

Cysts

Bone Cysts

Calcium

Calcium, Dietary

Mehan ALTAIFI

Nathalie BAUDRY

Sébastien PARRATTE, MD, Prof.

Sébastien PARRATTE, MD, Prof

CPC REGISTRY is a multi-center, international, prospective, open-label, observational study on the use of injectable calcium phosphate cements for the treatment of bone defects in adults. All patients will be treated with any of the two injectable calcium phosphate bone substitutes (GRAFTYS®HBS/GRAFTYS®Quickset or their private labels) according to standard clinical practice and according to the information provided by GRAFTYS manufacturer in respective device Instructions For Use (IFU).

The objective of this observational prospective study is to collect safety and performance data relating to the use of injectable Calcium Phosphate Cements "GRAFTYS®HBS/GRAFTYS®Quickset (or their private labels)" in routine clinical practice from various international hospitals. Therefore this observational study will allow to support data about risk management (established at the end of the product development); and to enhance the current clinical evaluation of products with new clinical data (for longer follow-up). The collected data of this observational study will be "non-identifying data". The patient must have signed a Written Consent Form (for data collection) prior to any data being entered into the electronic Case Report Form.

Patients will be followed as per local standard medical practices of the center for two years. Five follow-up visits/phone calls will be collected (at 3 months (+/-14 days), 6 months (+/- 14 days), 9 months (+/-21 days), 12 months (+/- 30 days) and 24 months (+/-60 days)). Each visit/phone call includes the collection of Adverse Events, the measurement of health status (quality of life and functional scores) and the X-ray scoring (if X-ray imaging is available). No additional exams (other than the routine clinical practice) are requested. The surgeons have to follow their usual practices (e.g. X-Rays have to be performed only if they are scheduled in the routine clinical practice).

All Adverse Events will be collected and monitored at each follow-up visit or follow-up phone call. All Serious Adverse Events must be described via a Serious Adverse Event form in e-CRF and all Adverse Device Effects must be described via a "Product Complaint Form" in e-CRF.

Descriptive analyses will be performed in order to describe: nature of adverse events, their distribution and frequency. Moreover, all factors which may appear predictive for the rate of adverse events will be analyzed (age, sex, amount of CPC injected, delivery system used, diabetes history, smoking habits, alcohol consumption, concomitant treatments/diseases...). For all time-dependent events, life-tables will be able to calculate using the Kaplan Meier estimate method, for a period starting on the date of the procedure up to and including the 24-months follow-up visit.

Calcium Phosphate Cement Registry (CPC Registry)

Observational Prospective Multi-center International Study on the Use of Injectable Calcium Phosphate Cements for the Treatment of Bone Defects in Adults.

Rate of Adverse Events related to bone substitutes (registry devices) for the follow-up period of patients.

Technical Success rate defined as successful delivery of the bone substitute in the target defect bone without evidence of delivery device or bone substitute malfunction. (NOTE: Malfunction is definied as a failure of the medical device to perform in accordance with its intended purpose when used in accordance with the Instructions For Uses (IFU)).

Device deficiency is defined as an inadequacy of a medical device with respect to its identity, quality, durability, reliability, safety or performance.

NOTE: Device deficiencies include malfunctions, use errors, and inadequate labelling.

Serious Adverse Event is defined as any adverse event that:

1. Led to a death,
2. Led to serious deterioration in health of the subject that either resulted in:

   1. a life-threatening illness or injury, or
   2. a permanent impairment of a body structure or a body function, or
   3. in-patient or prolonged hospitalization, or
   4. medical or surgical intervention to prevent life-threatening illness or injury or permanent impairment to a body structure or a body function.
3. Led to fetal distress, fetal death or a congenital abnormality or birth defect.

X-ray scoring systems have been implemented according to the medical literature criteria. For trauma defects/arthrodesis, the results are scored using the criteria proposed by Lane and Sandhu (bone formation, union and remodeling) and also including a bone substitute resorption (radiolucency) criteria. As for prosthesis revision/cavity defects, the scoring system includes bone substitute resorption, bone formation, remodeling and presence or absence of a radiolucent line between the bone and the cement/implant. The maximum score for both groups (trauma/arthrodesis \& cavity filling/arthroplasty) is 10/10 (excellent consolidation/excellent secondary stabilization) and the minimum score is 0/10 (no consolidation/no secondary stabilization).

This health status information is collected before and after a procedure and provides an indication of the clinical outcomes or quality of care delivered to patients. EQ-5D-3L paper questionnaire will be self-administered or it will be administered to patient via a telephone interview. The EQ-5D-5L still consists of 2 parts - the EQ-5D-5L descriptive system and the EQ VAS. The descriptive system comprises 5 dimensions (mobility, self-care, usual activities, pain/discomfort and anxiety/depression). Each dimension has 3 levels: no problems, some problems, extreme problems. EQ VAS is a scale on which the "best imaginable health state" is marked 100 and the "worst imaginable state" is marked 0.

Functional scores are used to monitor the patient progress. The questionnaires concern the degree of difficulty (level of function) that the patient experienced in performing usual daily activities and higher level activities due to his bone defect. Therefore, the type of functional score depends on the skeletal region impacted by the bone defect:

* Hand/wrist/ elbow/shoulder: Quick-DASH score (Disabilities of Arm, Shoulder \& Hand).
* Knee: KOOS-PS (Knee Injury \& Osteoarthritis Outcome Score- Physical function Short form)
* Hip: HOOS-PS (Hip disability and Osteoarthritis Outcome Score- Physical function Short form)
* Foot/Ankle: Kitaoka \& al's criteria, AOFAS Ankle-Hindfoot Scale; Forefoot Scale; Midfoot scale.

Surgeon's Satisfaction survey with registry device (about mixing ability, injecting ability and moldability) thanks to a 100-mm Visual Analog Scale (VAS). A score of zero indicated absolutely inacceptable, while a score of 100 indicated very satisfying.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Whole Body Magnetic Resonance Imaging Study	NCT04117594	Advanced Prosta...	WB-MRI	18 Years -	Royal Marsden NHS Foundation Trust
A Study to Assess BHQ880 in Combination With Zoledronic Acid in Relapsed or Refractory Myeloma Patients	NCT00741377	Multiple Myelom...	BHQ880 Zoledronic acid	18 Years - 78 Years	Novartis
XL184 For Relapsed/Refractory Multiple Myeloma (MM) With Bone Disease	NCT01582295	Multiple Myelom...	Cabozantinib	18 Years -	Massachusetts General Hospital
Exercise in Patients With Multiple Myeloma	NCT02439112	Multiple Myelom...	Exercise	18 Years -	Zealand University Hospital
XL184 For Relapsed/Refractory Multiple Myeloma (MM) With Bone Disease	NCT01582295	Multiple Myelom...	Cabozantinib	18 Years -	Massachusetts General Hospital
Calcium Phosphate Cement Registry (CPC Registry)	NCT02575352	Bone Disease Fracture Bone Bone Cyst		18 Years -	Graftys SA
Whole Body Magnetic Resonance Imaging Study	NCT04117594	Advanced Prosta...	WB-MRI	18 Years -	Royal Marsden NHS Foundation Trust

Spots Global Cancer Trial Database for bone disease

Every month we try and update this database with for bone disease cancer trials from around the world to help patients and their families find trials that might be right for them.
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