N/A N=142 Treatment

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

Differentiated Thyroid Cancer · Osteoporosis

Bottom Line

View on ClinicalTrials.gov: NCT02304757 ↗

Enrolled (actual)

142

Serious AEs

0.0%

Results posted

Oct 2021

Primary outcome: Primary: Percent Change of Bone Mineral Density in Lumbar and Hip — 3.0; 3.2; 3.8; 5.1 percentage change

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: 99Tc-MDP (Drug); Fosamax (Drug)
Age: Adult, Older Adult · 45+ yrs
Sex: Female
Sponsor: Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
Primary completion: Dec 2019

Outcome Measures

Outcome	Result	p-value
PRIMARY Percent Change of Bone Mineral Density in Lumbar and Hip	3.0; 3.2; 3.8; 5.1; 0.9; 4.9	—
SECONDARY Bone Turnover Markers	43.7725; 29.255; 52.6422; 20.56123; 0.4657; 0.1526	—
SECONDARY Health Related Quality of Life by 36-item Short Form Health Status Survey Questionnaire (0-100)	61.4; 64.4; 67.587; 69.09; 69; 68	—
SECONDARY Side Effects	0; 2; 0; 4	—

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.

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.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02304757). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.