Musculoskeletal Diseases

Nutritional and Metabolic Diseases

All Conditions

Mouth and Tooth Diseases

Diseases and Abnormalities at or Before Birth

Rare Diseases

Osteoporosis

Tooth Loss

Anodontia

Bone Diseases

Bone Diseases, Metabolic

Metabolic Diseases

Periodontal Diseases

Mouth Diseases

Stomatognathic Diseases

Tooth Diseases

Congenital Abnormalities

Tooth Abnormalities

Stomatognathic System Abnormalities

Bone Density Conservation Agents

All Drugs and Chemicals

Denosumab

Diphosphonates

Patient with osteoporosis - antiresorptive treatment \> 4 years who have had previous tooth extraction without development of MRONJ

Patient with osteoporosis - antiresorptive treatment \> 4 years who have lost teeth due to having previous osteonecrosis of the jaw which has been successfully surgically treated and healed for at least 3 months without recurrence

Patient with osteoporosis - antiresorptive treatment \> 4 years with ongoing osteonecrosis of the jaw to be surgically treated with block resection of the lower jaw and insertion of a titanium reconstruction plate. Simultaneous insertion of dental implants, or resection of the upper jaw where there is sufficient remaining bone volume to have implants inserted simultaneously (without bone augmentation)

Patient with cancer (breast, prostate or multiple myeloma) - adjuvant dose antiresorptive treatment who have had previous tooth extraction without development of MRONJ

Patient with cancer (breast, prostate or multiple myeloma) - adjuvant dose antiresorptive treatment who have lost teeth due to having previous osteonecrosis of the jaw which has been successfully surgically treated and healed for at least 3 months without recurrence

Patient with cancer (breast, prostate or multiple myeloma) - adjuvant dose antiresorptive treatment with ongoing osteonecrosis of the jaw to be surgically treated with block resection of the lower jaw and insertion of a titanium reconstruction plate. Simultaneous insertion of dental implants, or resection of the upper jaw where there is sufficient remaining bone volume to have implants inserted simultaneously (without bone augmentation)

Cancer patient treated with high dose antiresorptive treatment who have had previous tooth extraction without development of MRONJ

Cancer patient treated with high dose antiresorptive treatment who have lost teeth due to having previous osteonecrosis of the jaw which has been successfully surgically treated and healed for at least 3 months without recurrence

Cancer patients (breast, prostate or multiple myeloma) treated with high dose antiresorptive treatment with ongoing osteonecrosis of the jaw to be surgically treated with block resection of the lower jaw and insertion of a titanium reconstruction plate. Simultaneous insertion of dental implants, or resection of the upper jaw where there is sufficient remaining bone volume to have implants inserted simultaneously (without bone augmentation)

Dental surgery in patients treated with antiresorptive medication

Dental implant surgery

Prosthetic treatment and loading of the dental implants

Prosthetic treatment

Sanne Werner Moeller Andersen, DDS

Thomas Kofod, PhD

Thomas Steengaard Kofod, PhD

Aim of the study is to examine the feasibility of dental implant insertion in patients receiving high, adjuvant and low dose \> 4 years.

The hypothesis of the present study is that dental implant therapy using submerged healing is feasible and predictable in patients receiving high, adjuvant or low dose AR for more than 4 years, as documented by clinical and radiographic signs of osseointegration after 3-4 months, sufficient implant stability for abutment connection, and implant survival rates comparable to those of healthy individuals after one year of prosthetic loading.

Outcome of Dental Implant Therapy in Patients Treated With Antiresorptive Medication

Defined as presence of the implant in the jaw after initial implant surgery before abutment surgery

Defined as presence of the implant at time of final prosthetics

Defined as presence of the implant 1 year after loading of the final prosthetics

Defined as presence of the implant 2 years after loading of the final prosthetics

Defined as less marginal bone loss than 1.5 mm the first year, and 0.2 mm per year thereafter at time of assessment

Defined as no exposed bone, no fistula, no radiologic sign of MRONJ

Using OHIP-14 questionnaire to evaluate oral health-related quality of life

Performance of the EORTC questionnaire for the assessment of quality of life in head and neck cancer patients

Amgen

Institut Straumann AG

Copenhagen University Hospital at Herlev

Oral and Maxillofacial Surgeon

Neoplasms

Skin and Connective Tissue Diseases

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Symptoms and General Pathology

Breast Neoplasms

Prostatic Neoplasms

Neoplasm Metastasis

Genital Neoplasms, Male

Urogenital Neoplasms

Genital Diseases

Genital Diseases, Male

Urogenital Diseases

Prostatic Diseases

Male Urogenital Diseases

Zoledronic Acid

Pamidronate

Continue standard BMA frequency (every 4 or 12 weeks) as administered previously. If a change in BMA frequency (every 4 weeks to every 12 weeks OR every 12 weeks to every 4 weeks) was prescribed by the physician, this would still be considered on protocol treatment.

Bone modifying agent once every 24 weeks.

Bone modifying agent

Lisa Vandermeer

Marta Sienkiewicz

Terry Ng, MD

The investigators propose is to perform a pragmatic, multicenter, open-label, randomised clinical trial to demonstrate the efficacy and safety of either continuing or further de-escalating BMA after a minimum of two years of BMA treatment in patients with bone metastases from breast cancer and castration-resistant prostate cancer

Comparing Continuation or De-escalation of Bone Modifying Agents (BMA) in Patients Treated for Over 2 Years for Bone Metastases From Either Breast or Castration-resistant Prostate Cancer

A Randomised Trial Comparing Continuation or De-escalation of Bone Modifying Agents (BMA) in Patients Treated for Over 2 Years for Bone Metastases From Either Breast or Castration-resistant Prostate Cancer (REaCT-Hold BMA)

In the continuation arm, frequency of subsequent de-escalation or discontinuation of BMAs

In the de-escalation arm, frequency of restarting standard dosing BMA (and the reasons for restarting)

Health related quality of life (HR-QoL) scores measured by the European Organisation for Research and Treatment of Cancer (EORTC)-Quality of Life Questionnaire (QLQ)-C30 physical functioning subscale and the European Organisation for Research and Treatment of Cancer (EORTC)- Quality of Life Questionnaire (QLQ)- for patients with bone metastasis (BM)22 functional interference subscale. The EORTC-QLQ-C30 is an internationally accepted and validated tool in multiple large study cohorts capturing HR-QoL from a multi-dimensional and global perspective in oncology. EORTC-QLQ-BM22 has been validated for use specifically in bone metastases. They were developed in collaboration with patients, healthcare professionals and thorough review of the literature, and therefore important to all stakeholders; the scales are well-defined and easily measured, and HR-QoL is a relevant goal of care in the palliative care setting.

Number of patients with one or more SSEs (defined as: use of radiotherapy to relieve skeletal symtoms, new symptomatic pathological bone fractures \[vertebral or non-vertebral\], spinal cord compression, tumour-related orthopedic surgical intervention, or hypercalcaemia\] during trial period) up to 2 years post-randomization.

Defined from the date of randomization until the first date of patient experience an SSE. Any patient who does not experience an SSE will be censored on the last follow-up date and the patient can be confirmed as SSE-free (up to 2 years).

SSE-free survival (composite of time to first SSE and time to death)

Skeletal morbidity rate defined as ration of number of SSEs for each subject divided by the subject's time at risk in years.

Assess quality of life of cancer patients using the EORTC-QLQ-C30 (cancer patient specific questionnaire) at each time point, up to and including 48 weeks ("one year of treatment")

Assess quality of life of cancer patients using the EORTC-QLQ-BM22 (patients with bone metastases specific questionnaire) at each time point, up to and including 48 weeks ("one year of treatment")

BMA-related toxicity rates (up to 2 years) based on standard of care blood tests and clinical assessments

Defined as the difference in cost between two possible interventions, divided by the difference in their Quality Adjusted Life Year (QALY) gained.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Outcome of Dental Implant Therapy in Patients Treated With Antiresorptive Medication	NCT04741906	Missing Teeth Implants Cancer Osteoporosis	Dental implant ... Prosthetic trea...	-	Copenhagen University Hospital at Herlev
Outcome of Dental Implant Therapy in Patients Treated With Antiresorptive Medication	NCT04741906	Missing Teeth Implants Cancer Osteoporosis	Dental implant ... Prosthetic trea...	-	Copenhagen University Hospital at Herlev
Comparing Continuation or De-escalation of Bone Modifying Agents (BMA) in Patients Treated for Over 2 Years for Bone Metastases From Either Breast or Castration-resistant Prostate Cancer	NCT04549207	Breast Cancer Castration-resi...	Bone modifying ...	18 Years -	Ottawa Hospital Research Institute

Spots Global Cancer Trial Database for bone modifying agents