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Trial record 56 of 959 for:    bone tumors AND NOT metastatic | Recruiting, Not yet recruiting, Available Studies

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

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ClinicalTrials.gov Identifier: NCT02304757
Recruitment Status : Recruiting
First Posted : December 2, 2014
Last Update Posted : September 6, 2018
Sponsor:
Information provided by (Responsible Party):
Chao Ma, Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

Brief 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).

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.


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Study Type : Interventional  (Clinical Trial)
Estimated 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
Estimated Primary Completion Date : June 30, 2019
Estimated Study Completion Date : June 30, 2019


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




Primary Outcome Measures :
  1. 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 :
  1. 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

  2. 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.

  3. 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.

  4. side effects [ Time Frame: 3, 6 and 12 months after treatment. ]
    A transient rash and phlebitis, gastrointestinal reaction.



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

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


Contacts
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Contact: Hui Wang, MD 86-02125078590 wanghauishanghai@hotmail.com
Contact: Chao Ma, MD 86-02125078593 mc_7419@hotmail.com

Locations
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China, Shanghai
Nuclear Medicine Xinhua Hospital Recruiting
Shanghai, Shanghai, China, 200092
Contact: Chao Ma, MD    +86021-25078593    mc_7419@hotmail.com   
Contact: Hui Wang, MD    +86021-25078593    wanghuishanghai@hotmail.com   
Sub-Investigator: Yanlei Huo, BA         
Sub-Investigator: Suyun Chen, MD         
Sub-Investigator: Danyang Wang, BA         
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

Publications of Results:
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Responsible Party: Chao Ma, Dr., Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
ClinicalTrials.gov Identifier: NCT02304757     History of Changes
Other Study ID Numbers: SanghaiXinhua
First Posted: December 2, 2014    Key Record Dates
Last Update Posted: September 6, 2018
Last Verified: September 2018
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
Bone Diseases, Metabolic
Bone Diseases
Endocrine Gland Neoplasms
Neoplasms by Site
Neoplasms
Head and Neck Neoplasms
Bone Density Conservation Agents
Thyroid Diseases
Osteoporosis
Endocrine System Diseases
Musculoskeletal Diseases
Metabolic Diseases
Vitamins
Vitamin D
Ergocalciferols
Cholecalciferol
Alendronate
Methylene diphosphonate
Calcium
Calcium Carbonate
Micronutrients
Nutrients
Growth Substances
Physiological Effects of Drugs
Calcium-Regulating Hormones and Agents
Antacids
Molecular Mechanisms of Pharmacological Action
Gastrointestinal Agents