99Tc-MDP in Postmenopausal Women With Differentiated Thyroid Cancer and Decreased Bone Mineral Density
Conditions
Differentiated Thyroid Cancer - Osteoporosis
Conditions: official terms
Thyroid Diseases - Thyroid Neoplasms
Conditions: Keywords
differentiated thyroid cancer, bone mineral density, thyroid stimulating hormone suppression
Study Type
Interventional
Study Phase
N/A
Study Design
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment
Intervention
Name: 99Tc-MDP Type: Drug
Name: fosamax Type: Drug
Name: Caltrate Type: Drug
Overall Status
Not yet recruiting
Summary
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, calcium containing vitamin D alone and fosamax (alendronate sodium) in postmenopausal women with DTC and decreased bone mineral density (BMD).
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.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: N/A
Minimum Age: N/A
Gender: Female
Criteria: Inclusion Criteria:

1. Postmenopausal participants;

2. Histologically established differentiated thyroid cancer (DTC) ;

3. Total or near total thyroidectomy and radioiodine-131 thyroid residual ablation;

4. Suppressive doses of levothyroxine (L-T4) with thyroid stimulating hormone( )≦the lower limit of the normal reference value;

5. Participants voluntarily participate In the trial, and signed the informed consent.

Exclusion Criteria:

1. Secondary osteoporosis;

2. Osteoporosis receiving treatment;

3. Severe liver and kidney disease, bone marrow suppression;

4. Esophageal reflux gastritis;

5. Long term oral immunosuppressant, estrogen, selective estrogen receptor modulators.
Location
Start Date
January 2015
Completion Date
August 2016
Sponsors
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
Source
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page