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

Osteoporosis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02304757
• Other study ID #: SanghaiXinhua
• Status: Completed
• Phase: N/A
• Start date: January 2015
• Est. completion date: December 30, 2019

Study information

• Verified date: November 2021
• Source: Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 142
• Est. completion date: December 30, 2019
• Est. primary completion date: December 30, 2019
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 45 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Differentiated Thyroid Cancer
• Osteoporosis
• Thyroid Diseases
• Thyroid Neoplasms

Intervention

Drug:
• 99Tc-MDP
99Tc-MDP, H20000218
• Fosamax
H20080172

Locations

Country	Name	City	State
China	Nuclear Medicine Xinhua Hospital	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Bone Turnover Markers	bone turnover markers including C-telopeptides of type I collagen (CTX), Type I N-procollagen terminal propeptide(PINP)	baseline and 12 months
Secondary	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.	baseline, 6 months, and 12 months
Secondary	Side Effects	A transient rash and phlebitis, gastrointestinal reaction.	6 months, and 12 months