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

Primary Purpose

Differentiated Thyroid Cancer, Osteoporosis

Status

Completed

Phase

Not Applicable

Locations

China

Study Type

Interventional

Intervention

99Tc-MDP

Fosamax

About this trial

This is an interventional treatment trial for Differentiated Thyroid Cancer focused on measuring differentiated thyroid cancer, bone mineral density, thyroid stimulating hormone suppression

Eligibility Criteria

45 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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:

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.

Sites / Locations

Nuclear Medicine Xinhua Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

99Tc-MDP

Fosamax

Arm Description

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.

70mg po every week for 12 months.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Bone Turnover Markers

bone turnover markers including C-telopeptides of type I collagen (CTX), Type I N-procollagen terminal propeptide(PINP)

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

The health related quality of life was measured by 36-item Short Form Health Status Survey questionnaire (SF-36). The minimum and maximum values were 0 and 100, respectively. Higher scores mean a better a better outcome. The questionnaire includes 36 items that can be classified into the following eight health status subscales: Physical Functioning, Physical Role Limitations, Bodily Pain, General Health Perception, Vitality, Social Functioning, Emotional Role Limitations, and Mental Health. A standardized Physical Component Summary and a standardized mental component score were calculated. The physical component summary and mental component summary represent the deviation from the reference population in Sweden. Higher scores mean a better a better outcome.

Side Effects

A transient rash and phlebitis, gastrointestinal reaction.

Full Information

NCT ID

NCT02304757

First Posted

November 24, 2014

Last Updated

November 16, 2021

Sponsor

Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

1. Study Identification

Unique Protocol Identification Number

NCT02304757

Brief Title

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

Official Title

Prospective Trial of 99Tc-MDP and Fosamax in Postmenopausal Women With Differentiated Thyroid Cancer and Osteoporosis Treated With Supraphysiological Doses of Thyroid Hormone

Study Type

Interventional

2. Study Status

Record Verification Date

November 2021

Overall Recruitment Status

Completed

Study Start Date

January 2015 (Actual)

Primary Completion Date

December 30, 2019 (Actual)

Study Completion Date

December 30, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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.

Detailed Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Differentiated Thyroid Cancer, Osteoporosis

Keywords

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Model Description

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

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

142 (Actual)

8. Arms, Groups, and Interventions

Arm Title

99Tc-MDP

Arm Type

Experimental

Arm Description

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.

Arm Title

Fosamax

Arm Type

Active Comparator

Arm Description

70mg po every week for 12 months.

Intervention Type

Drug

Intervention Name(s)

99Tc-MDP

Other Intervention Name(s)

Yunke,Technetium [99Tc] Methylenediphosphonate

Intervention Description

99Tc-MDP, H20000218

Intervention Type

Drug

Intervention Name(s)

Fosamax

Other Intervention Name(s)

alendronate sodium

Intervention Description

H20080172

Primary Outcome Measure Information:

Title

Percent Change of Bone Mineral Density in Lumbar and Hip

Description

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

Time Frame

baseline, 6 months, and 12 months

Secondary Outcome Measure Information:

Title

Bone Turnover Markers

Description

bone turnover markers including C-telopeptides of type I collagen (CTX), Type I N-procollagen terminal propeptide(PINP)

Time Frame

baseline and 12 months

Title

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

Description

Time Frame

baseline, 6 months, and 12 months

Title

Side Effects

Description

A transient rash and phlebitis, gastrointestinal reaction.

Time Frame

6 months, and 12 months

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

45 Years

Accepts Healthy Volunteers

Eligibility Criteria

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: 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Chao Ma, MD

Organizational Affiliation

Shanghai 10th People's Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

Nuclear Medicine Xinhua Hospital

City

Shanghai

State/Province

Shanghai

ZIP/Postal Code

200092

Country

China

12. IPD Sharing Statement

Plan to Share IPD

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

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