99Tc-MDP in Postmenopausal Women With Differentiated Thyroid Cancer and Decreased Bone Mineral Density
Information source: Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Differentiated Thyroid Cancer; Osteoporosis
Intervention: 99Tc-MDP (Drug); fosamax (Drug); Caltrate (Drug)
Phase: N/A
Status: Not yet recruiting
Sponsored by: Xinhua Hospital, Shanghai Jiao Tong University School of Medicine Official(s) and/or principal investigator(s): Chao Ma, MD, Principal Investigator, Affiliation: Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
Overall contact: Hui Wang, MD, Phone: 86-02125078590, Email: wanghauishanghai@hotmail.com
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).
Clinical Details
Official title: Randomized 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 design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment
Primary outcome: bone mineral density in lumbar and hip
Secondary outcome: bone turnover markersbone pain by numerical rating scale health-related quality of life side effects
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.
Eligibility
Minimum age: N/A.
Maximum age: N/A.
Gender(s): 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.
Locations and Contacts
Hui Wang, MD, Phone: 86-02125078590, Email: wanghauishanghai@hotmail.com Additional Information
Starting date: January 2015
Last updated: January 30, 2015
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