Musculoskeletal Diseases

Nutritional and Metabolic Diseases

All Conditions

Neoplasms

Gland and Hormone Related Diseases

Osteoporosis

Thyroid Neoplasms

Thyroid Diseases

Endocrine System Diseases

Bone Diseases

Bone Diseases, Metabolic

Metabolic Diseases

Endocrine Gland Neoplasms

Head and Neck Neoplasms

All Drugs and Chemicals

Bone Density Conservation Agents

Hormones

Alendronate

Methylene diphosphonate

Diphosphonates

15mg 99Tc-MDP were intravenously administered twice a week for 10 weeks, then once a week for 8 weeks, every two weeks for 22 weeks and monthly for another 3m.

99Tc-MDP

Fosamax

Chao Ma, MD

Postmenopausal women with differentiated thyroid cancer (DTC) taking suppressive doses of levothyroxine (L-T4) are thought to have accelerated bone loss and increased risk of osteoporosis. Therefore, the investigators try to investigate the effects of 99Tc-MDP,alendronate sodium in postmenopausal women with DTC under TSH suppression and osteoporosis.

Differentiated thyroid cancer (DTC) has become one of the most common endocrine malignancies. According to American Thyroid Association (ATA) and Chinese Thyroid Association (CTA), most of DTC patients undergo total or near total thyroidectomy, radioiodine ablation and TSH (thyroid stimulating hormone) suppression. Osteoporosis (OS) and fractures are important comorbidities in patients with DTC, with potential negative impact on quality of life (QOL) and survival. The main determinant of skeletal fragility in DTC is the TSH suppression. Postmenopausal women with DTC under TSH suppression therapy are more vulnerable to OS. Technetium-99 methylene diphosphonate (99Tc-MDP) is a decay product of 99mTc-MDP (used for bone scintigraphy) and a novel bisphosphonates, which has been used in China for diseases like rheumatoid arthritis (RA), ankylosing spondylitis (AS) and osteochondral lesions of the talus, etc. However, as a member of bisphosphates, little attention has been paid to its anti-OS effect for DTC under TSH suppression.

Patients with OS were divided into 99Tc-MDP and fosamax treatment groups.

99Tc-MDP in Postmenopausal Women With Differentiated Thyroid Cancer and Osteoporosis

Prospective Trial of 99Tc-MDP and Fosamax in Postmenopausal Women With Differentiated Thyroid Cancer and Osteoporosis Treated With Supraphysiological Doses of Thyroid Hormone

Percent change of bone mineral density in lumbar and hip by dual energy x-ray absorptiometry

bone turnover markers including C-telopeptides of type I collagen (CTX), Type I N-procollagen terminal propeptide(PINP)

The health related quality of life was measured by 36-item Short Form Health Status Survey questionnaire (SF-36). The minimum and maximum values were 0 and 100, respectively. Higher scores mean a better a better outcome.

The questionnaire includes 36 items that can be classified into the following eight health status subscales: Physical Functioning, Physical Role Limitations, Bodily Pain, General Health Perception, Vitality, Social Functioning, Emotional Role Limitations, and Mental Health. A standardized Physical Component Summary and a standardized mental component score were calculated. The physical component summary and mental component summary represent the deviation from the reference population in Sweden. Higher scores mean a better a better outcome.

A transient rash and phlebitis, gastrointestinal reaction.

Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

15mg 99Tc-MDP were intravenously administered twice a week for 10 weeks, then once a week for 8 weeks, every two weeks for 22 weeks and monthly for another 3m.

99Tc-MDP: 99Tc-MDP, H20000218

70mg po every week for 12 months.

Alendronate Sodium: H20080172

Total

Age, Continuous

Sex: Female

Sex/Gender, Customized

Race and Ethnicity were not collected from any participant.

Race and Ethnicity Not Collected

China

Region of Enrollment

T1N0-1

T2N0-1

T3N0-1

T4N0-1

TxNx

TxN0-1

T1-2Nx

T1N0-1, indicated participants had tumor ≤2 cm in greatest dimension, and with (N1) or without (N0)metastasis to lymph node; T2N0-1, tumor size \>2 cm but ≤4 cm in greatest dimension, and with or without metastasis to lymph node; T3N0-1, tumor size \>4 cm, and with or without metastasis to lymph node; TxNX, indicated participants had unknown tumor size and unknown metastasis to lymph node; TxN0-1, indicated participants had unknown tumor size, and with or without metastasis to lymph node; T1-2Nx, tumor ≤2 cm(T1) or \>2 cm but ≤4 cm (T2), and unknown metastasis to lymph node.

TNM staging

Chao Ma

Percentage change of lumbar spine at month 6

Percentage change of lumbar spine month 12

Percentage change of total hip at month 6

Percentage change of total hip at month 12

Percent Change of Bone Mineral Density in Lumbar and Hip

PINP before treatment

PINP at 12months

CTX before treatment

CTX at 12months

Bone Turnover Markers

Physical component summary at baseline by 36-item Short Form Health Status Survey questionnaire

Physical component summary at 6months by 36-item Short Form Health Status Survey questionnaire

Physical component summary at 12months by 36-item Short Form Health Status Survey questionnaire

Mental component score at baseline by 36-item Short Form Health Status Survey questionnaire

Mental component score at 6months by 36-item Short Form Health Status Survey questionnaire

Mental component score at 12months by 36-item Short Form Health Status Survey questionnaire (0-100)

Health Related Quality of Life by 36-item Short Form Health Status Survey Questionnaire (0-100)

abdominal pain

dyspepsia

Side Effects

Overall Study

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
99Tc-MDP in Postmenopausal Women With Differentiated Thyroid Cancer and Osteoporosis	NCT02304757	Differentiated ... Osteoporosis	99Tc-MDP Fosamax	45 Years -	Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
99Tc-MDP in Postmenopausal Women With Differentiated Thyroid Cancer and Osteoporosis	NCT02304757	Differentiated ... Osteoporosis	99Tc-MDP Fosamax	45 Years -	Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

Spots Global Cancer Trial Database for fosamax

Every month we try and update this database with for fosamax cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for fosamax

Every month we try and update this database with for fosamax cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for fosamax cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.