Clinical trial NCT02304757: 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
Overall status: COMPLETED
Phase: NA
Conditions: Differentiated Thyroid Cancer
Osteoporosis
Keywords: differentiated thyroid cancer
bone mineral density
thyroid stimulating hormone suppression
Lead sponsor: Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
Sponsor class: OTHER
First posted: 2014-12-02
Enrollment: 142
Sex: FEMALE
Minimum age (years): 45
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Patients with OS were divided into 99Tc-MDP and fosamax treatment groups.
Primary purpose: TREATMENT

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.

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:

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.

Primary outcomes:
measure: Percent Change of Bone Mineral Density in Lumbar and Hip
timeFrame: baseline, 6 months, and 12 months
Secondary outcomes:
measure: Bone Turnover Markers
timeFrame: baseline and 12 months
measure: Health Related Quality of Life by 36-item Short Form Health Status Survey Questionnaire (0-100)
timeFrame: baseline, 6 months, and 12 months
measure: Side Effects
timeFrame: 6 months, and 12 months
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Nuclear Medicine Xinhua Hospital
state: Shanghai
Study officials:
affiliation: Shanghai 10th People's Hospital
name: Chao Ma, MD
role: PRINCIPAL_INVESTIGATOR
References: