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

NCT ID: NCT02304757

Last Updated: 2021-11-17

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

142 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-01-31

Study Completion Date

2019-12-30

Brief Summary

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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.

Detailed Description

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Differentiated thyroid cancer (DTC) has become one of the most common endocrine malignancies. According to American Thyroid Association (ATA) and Chinese Thyroid Association (CTA), most of DTC patients undergo total or near total thyroidectomy, radioiodine ablation and TSH (thyroid stimulating hormone) suppression. Osteoporosis (OS) and fractures are important comorbidities in patients with DTC, with potential negative impact on quality of life (QOL) and survival. The main determinant of skeletal fragility in DTC is the TSH suppression. Postmenopausal women with DTC under TSH suppression therapy are more vulnerable to OS. Technetium-99 methylene diphosphonate (99Tc-MDP) is a decay product of 99mTc-MDP (used for bone scintigraphy) and a novel bisphosphonates, which has been used in China for diseases like rheumatoid arthritis (RA), ankylosing spondylitis (AS) and osteochondral lesions of the talus, etc. However, as a member of bisphosphates, little attention has been paid to its anti-OS effect for DTC under TSH suppression.

Conditions

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Differentiated Thyroid Cancer Osteoporosis

Keywords

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differentiated thyroid cancer bone mineral density thyroid stimulating hormone suppression

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Patients with OS were divided into 99Tc-MDP and fosamax treatment groups.
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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99Tc-MDP

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.

Group Type EXPERIMENTAL

99Tc-MDP

Intervention Type DRUG

99Tc-MDP, H20000218

Fosamax

70mg po every week for 12 months.

Group Type ACTIVE_COMPARATOR

Fosamax

Intervention Type DRUG

H20080172

Interventions

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99Tc-MDP

99Tc-MDP, H20000218

Intervention Type DRUG

Fosamax

H20080172

Intervention Type DRUG

Other Intervention Names

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Yunke,Technetium [99Tc] Methylenediphosphonate alendronate sodium

Eligibility Criteria

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Inclusion Criteria

(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.

Exclusion Criteria

1. patients having medications for osteoporosis before TSH suppression treatment;
2. secondary osteoporosis ;
3. severe liver or kidney disease;
4. myelosuppression;
5. digestive disease;
6. 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.
Minimum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

OTHER

Sponsor Role lead

Responsible Party

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Chao Ma

Dr.

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Chao Ma, MD

Role: PRINCIPAL_INVESTIGATOR

Shanghai 10th People's Hospital

Locations

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Nuclear Medicine Xinhua Hospital

Shanghai, Shanghai Municipality, China

Site Status

Countries

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China

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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SanghaiXinhua

Identifier Type: -

Identifier Source: org_study_id