99Tc-MDP in Postmenopausal Women With Differentiated Thyroid Cancer and Decreased Bone Mineral Density

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ClinicalTrials.gov Identifier: NCT02304757

Recruitment Status : Completed

First Posted : December 2, 2014

Last Update Posted : July 29, 2020

Sponsor:

Information provided by (Responsible Party):

Chao Ma, Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

Study Description

Brief Summary:

Condition or disease	Intervention/treatment	Phase
Differentiated Thyroid Cancer Osteoporosis	Drug: 99Tc-MDP Drug: fosamax Drug: Caltrate	Not Applicable

Detailed Description:

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 Technetium [99Tc] Methylenediphosphonate (99Tc-MDP), calcium containing vitamin D alone and fosamax (alendronate sodium) in postmenopausal women with DTC and decreased bone mineral density (BMD). The investigators therefore randomize 58 patients with slightly decreased BMD (T or Z-score in lumbar spine or neck region of femur > -2.0 SD by dual energy X-ray) taking suppressive doses of L-T4 to treatment with 99Tc-MDP (low dose) 10mg Intravenous drip every 1week for ten weeks, every 2 weeks for 22 weeks, every 1 month for 4 months, or calcium containing vitamin D alone. The control group, namely, 600mg calcium group containing vitamin D everyday. The investigators also randomize 148 patients with obviously decreased BMD (T or Z-score in lumbar spine or neck region of femur≤-2.0 SD) taking suppressive doses of L-T4 to treatment with 99Tc-MDP (high dose)15mg ivdripIntravenous drip every 1week for ten weeks, every 2 weeks for 22 weeks, every 1 month for 4 months (99Tc-MDP), or fosamax 70mg po for 12 months. BMD of the spine and hip will be measured by dual energy x-ray absorptiometry bone densitometer. The spine was measured in the posterior projection, and results are reported for the total spine lumbar 1-4. The hip was measured in the standard projection, and results are reported for femoral neck, trochanter, and total hip; the femoral neck was chosen to represent a site rich in cortical bone, and the trochanter to represent a site relatively rich in trabecular bone. Patients have measurements of serum alkaline phosphatase, bone turnover markers, osteocalcin, C-telopeptides of type I collagen (CTX), Type I N-procollagen terminal propeptide,etc every 3, months for 1 yr. We also evaluate the bone pain by numerical rating scale (NRS), the quality of life by Short Form-36 (SF-36) scores.

All assays were performed by a technician who was blinded regarding the subjects' treatment assignment.

Study Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	206 participants
Allocation:	Non-Randomized
Intervention Model:	Parallel Assignment
Masking:	None (Open Label)
Primary Purpose:	Treatment
Official Title:	Prospective Trial of 99Tc-MDP and Alendronate Sodium in Postmenopausal Women With Differentiated Thyroid Cancer and Decrease in Bone Mineral Density Treated With Supraphysiological Doses of Thyroid Hormone
Study Start Date :	January 2015
Actual Primary Completion Date :	December 30, 2019
Actual Study Completion Date :	December 30, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bone Density Minerals Thyroid Cancer Thyroid Diseases

Drug Information available for: Calcium carbonate Thyroid Alendronic acid Alendronate sodium

U.S. FDA Resources

Arms and Interventions

Arm	Intervention/treatment
Experimental: low dose 99Tc-MDP Patients with slightly decreased BMD (T or Z-score in lumbar spine or neck region of femur > -2.0 SD by dual energy X-ray) taking suppressive doses of L-T4 to treatment divided into 2 groups of 99Tc-MDP (Technetium [99Tc] methylenediphosphonate) and calcium alone.99Tc-MDP group:10mg Intravenous drip every 1week for ten weeks, every 2weeks for 22 weeks, every 1 month for 4 months.	Drug: 99Tc-MDP 99Tc-MDP, H20000218 Other Name: Yunke,Technetium [99Tc] Methylenediphosphonate Drug: Caltrate Calcium 600 mg and vitamine D3 125iu. Other Name: Calcium Carbonate and Vitamin D3 tablet
Active Comparator: Caltrate 600mg caltrate containing vitamin D everyday for 12 months.	Drug: Caltrate Calcium 600 mg and vitamine D3 125iu. Other Name: Calcium Carbonate and Vitamin D3 tablet
Experimental: high dose 99Tc-MDP 148 patients with obviously decreased BMD (T or Z-score in lumbar spine or neck region of femur≤-2.0 SD) taking suppressive doses of L-T4 divided into 2 groups of 99Tc-MDP and or fosamax. 99Tc-MDP group:15mg 99Tc-MDP Intravenous drip every 1week for ten weeks, every 2weeks for 22 weeks, every 1 month for 4 months (99Tc-MDP) for 12 months.	Drug: 99Tc-MDP 99Tc-MDP, H20000218 Other Name: Yunke,Technetium [99Tc] Methylenediphosphonate Drug: Caltrate Calcium 600 mg and vitamine D3 125iu. Other Name: Calcium Carbonate and Vitamin D3 tablet
Active Comparator: fosamax 70mg po every week for 12 months.	Drug: fosamax H20080172 Other Name: alendronate sodium Drug: Caltrate Calcium 600 mg and vitamine D3 125iu. Other Name: Calcium Carbonate and Vitamin D3 tablet

Outcome Measures

Primary Outcome Measures :

bone mineral density in lumbar and hip [ Time Frame: 0, and 3, 6, 12 months after treatment. ]
The changes of T score in lumbar and hip by dual energy x-ray absorptiometry

Secondary Outcome Measures :

bone turnover markers [ Time Frame: 0, and 3, 6, 12 months after treatment. ]
bone turnover markers including osteocalcin, C-telopeptides of type I collagen (CTX), Type I N-procollagen terminal propeptide
bone pain by numerical rating scale [ Time Frame: 0, and 3, 6, 12 months after treatment. ]
On numerical rating scale of 0 to 10 where 0 is no pain and 10 is the worst pain.
health-related quality of life [ Time Frame: 0, and 3, 6, 12 months after treatment. ]
health-related quality of life questionnaire by Short Form-36 (SF-36) scores including physical health (physical functioning; physical role; bodily pain; general health) ;Mental health (vitality; social functioning; emotional role; mental health).Minimum score 0,maximum score, scores above 50 are better than the general population average for all scales, while scores below 50 are worse.
side effects [ Time Frame: 3, 6 and 12 months after treatment. ]
A transient rash and phlebitis, gastrointestinal reaction.

Eligibility Criteria

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Ages Eligible for Study:	Child, Adult, Older Adult
Sexes Eligible for Study:	Female
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Postmenopausal participants;
Histologically established differentiated thyroid cancer (DTC) ;
Total or near total thyroidectomy and radioiodine-131 thyroid residual ablation;
Suppressive doses of levothyroxine (L-T4) with thyroid stimulating hormone( )≦the lower limit of the normal reference value;
Participants voluntarily participate In the trial, and signed the informed consent.

Exclusion Criteria:

Secondary osteoporosis;
Osteoporosis receiving treatment;
Severe liver and kidney disease, bone marrow suppression;
Esophageal reflux gastritis;
Long term oral immunosuppressant, estrogen, selective estrogen receptor modulators.

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02304757

Locations

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China, Shanghai
Nuclear Medicine Xinhua Hospital
Shanghai, Shanghai, China, 200092

Sponsors and Collaborators

Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

Investigators

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Principal Investigator:	Chao Ma, MD	Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

More Information

Publications of Results:

McGriff NJ, Csako G, Gourgiotis L, Lori C G, Pucino F, Sarlis NJ. Effects of thyroid hormone suppression therapy on adverse clinical outcomes in thyroid cancer. Ann Med. 2002;34(7-8):554-64.

Quan ML, Pasieka JL, Rorstad O. Bone mineral density in well-differentiated thyroid cancer patients treated with suppressive thyroxine: a systematic overview of the literature. J Surg Oncol. 2002 Jan;79(1):62-9; discussion 69-70. Review.

Heemstra KA, Hamdy NA, Romijn JA, Smit JW. The effects of thyrotropin-suppressive therapy on bone metabolism in patients with well-differentiated thyroid carcinoma. Thyroid. 2006 Jun;16(6):583-91.

Rosen HN, Moses AC, Garber J, Ross DS, Lee SL, Ferguson L, Chen V, Lee K, Greenspan SL. Randomized trial of pamidronate in patients with thyroid cancer: bone density is not reduced by suppressive doses of thyroxine, but is increased by cyclic intravenous pamidronate. J Clin Endocrinol Metab. 1998 Jul;83(7):2324-30.

Gong W, Dou H, Liu X, Sun L, Hou Y. Technetium-99 conjugated with methylene diphosphonate inhibits receptor activator of nuclear factor-κB ligand-induced osteoclastogenesis. Clin Exp Pharmacol Physiol. 2012 Oct;39(10):886-93. doi: 10.1111/j.1440-1681.2012.12006.x.

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Responsible Party:	Chao Ma, Dr., Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
ClinicalTrials.gov Identifier:	NCT02304757
Other Study ID Numbers:	SanghaiXinhua
First Posted:	December 2, 2014 Key Record Dates
Last Update Posted:	July 29, 2020
Last Verified:	July 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD:	No

Keywords provided by Chao Ma, Xinhua Hospital, Shanghai Jiao Tong University School of Medicine:


differentiated thyroid cancer bone mineral density thyroid stimulating hormone suppression

Additional relevant MeSH terms:

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Thyroid Neoplasms Osteoporosis Thyroid Diseases Endocrine System Diseases Bone Diseases, Metabolic Bone Diseases Musculoskeletal Diseases Metabolic Diseases Endocrine Gland Neoplasms Neoplasms by Site Neoplasms Head and Neck Neoplasms Vitamin D	Alendronate Methylene diphosphonate Calcium Carbonate Vitamins Micronutrients Nutrients Growth Substances Physiological Effects of Drugs Bone Density Conservation Agents Antacids Molecular Mechanisms of Pharmacological Action Gastrointestinal Agents

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