DrugLib.com — Drug Information Portal

Rx drug information, pharmaceutical research, clinical trials, news, and more



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 markers

bone 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

Page last updated: August 23, 2015

-- advertisement -- The American Red Cross
 
Home | About Us | Contact Us | Site usage policy | Privacy policy

All Rights reserved - Copyright DrugLib.com, 2006-2017