99Tc-MDP in Postmenopausal Women With Differentiated Thyroid Cancer and Osteoporosis

NCT02304757 | Completed Results DMC

• 1 other identifier: SanghaiXinhua
• Study Type: interventional
• Target: 142
• Locations: 1 country
• Sites: 1

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,alendronate sodium in postmenopausal women with DTC under TSH suppression and osteoporosis.

Conditions

Differentiated Thyroid Cancer; Osteoporosis

Keywords

differentiated thyroid cancer; bone mineral density; thyroid stimulating hormone suppression

Outcome Measures

Primary Outcomes (1)

• Percent Change of Bone Mineral Density in Lumbar and Hip

  Percent change of bone mineral density in lumbar and hip by dual energy x-ray absorptiometry

  baseline, 6 months, and 12 months

Secondary Outcomes (3)

• Bone Turnover Markers

  baseline and 12 months

• Health Related Quality of Life by 36-item Short Form Health Status Survey Questionnaire (0-100)

  baseline, 6 months, and 12 months

• Side Effects

  6 months, and 12 months

Study Arms (2)

99Tc-MDP

EXPERIMENTAL

15mg 99Tc-MDP were intravenously administered twice a week for 10 weeks, then once a week for 8 weeks, every two weeks for 22 weeks and monthly for another 3m.

Drug: 99Tc-MDP

Fosamax

ACTIVE COMPARATOR

70mg po every week for 12 months.

Drug: Fosamax

Interventions

99Tc-MDP DRUG

99Tc-MDP, H20000218

Also known as: Yunke,Technetium [99Tc] Methylenediphosphonate

99Tc-MDP

Fosamax DRUG

H20080172

Also known as: alendronate sodium

Fosamax

Eligibility Criteria

• Age: 45 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• (1) They were pathologically diagnosed with DTC including papillary or follicular carcinoma. (2) They received a near total thyroidectomy and radioiodine treatment. (3) TSH suppression should be at least one year before the study. (4) Bone mineral density (BMD) in lumbar spine and/or hip was tested by Dual-energy X-ray absorptiometry (DXA) at baseline, 6 month (m) and/or 12m follow up. 5) The diagnosis of osteoporosis was T-score ≤-2.5 SD at the lumbar spine, or hip.

You may not qualify if:

• patients having medications for osteoporosis before TSH suppression treatment;
• secondary osteoporosis ;
• severe liver or kidney disease;
• myelosuppression;
• digestive disease;
• long term use of immunosuppressive agent, estrogen or estrogen receptor modulators. This study was approved by the Institutional Review Board of Hospital Research Ethics. All the patients were fully acquainted with their treatment and consented to participate in the clinical trial.

Sponsors & Collaborators

• Xinhua Hospital, Shanghai Jiao Tong University School of Medicine: lead

Study Sites (1)

Nuclear Medicine Xinhua Hospital

Shanghai, Shanghai Municipality, 200092, China

Location

MeSH Terms

Conditions

Osteoporosis

Interventions

Technetium; Alendronate

Condition Hierarchy (Ancestors)

Bone Diseases, Metabolic; Bone Diseases; Musculoskeletal Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Elements, Radioactive; Elements; Inorganic Chemicals; Metals, Heavy; Transition Elements; Radioisotopes; Isotopes; Metals; Diphosphonates; Organophosphonates; Organophosphorus Compounds; Organic Chemicals

Results Point of Contact

• Title: Chao Ma
• Organization: Tenth People's Hospital of Tongji University

mc_7419@hotmail.com

02125078593

Study Officials

• Chao Ma, MD

  Shanghai 10th People's Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr.

Model Details: Patients with OS were divided into 99Tc-MDP and fosamax treatment groups.

Study Record Dates

• First Submitted: November 24, 2014
• First Posted: December 2, 2014
• Study Start: January 1, 2015
• Primary Completion: December 30, 2019
• Study Completion: December 30, 2019
• Last Updated: November 17, 2021
• Results First Posted: October 18, 2021

Record last verified: 2021-11

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)