Type 2 Diabetes Clinical Trial
Official title:
Efficacy of Bisphosphonate Therapy on Postmenopausal Osteoporotic Women With and Without Diabetes: a Prospective Trial
Verified date | February 2022 |
Source | Yeouido St. Mary's Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The purpose of this study is to examine whether monthly oral administration of ibandronate to postmenopausal osteoporosis patients with type 2 diabetes differs in safety and efficacy compared to patients without diabetes.
Status | Completed |
Enrollment | 121 |
Est. completion date | January 31, 2022 |
Est. primary completion date | August 30, 2021 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 55 Years and older |
Eligibility | Inclusion Criteria: - age of at least 55 years at the time of screening - postmenopausal woman - diagnosis of osteoporosis Exclusion Criteria: - history of osteoporosis treatment - underlying disease (e.g., heart failure, liver disease, renal disease, or malignancy) - the use of drugs that affect bone metabolism (e.g., steroids, immunosuppressants, gonadotropin-releasing hormone agonists, aromatase inhibitors, thiazolidinedione drugs, anticonvulsants, and antidepressants) - history of adverse effects of bisphosphonate or difficulty taking the drug due to an inability to sit or the presence of upper gastrointestinal disease |
Country | Name | City | State |
---|---|---|---|
Korea, Republic of | Yeouido St.Mary's Hospital | Seoul |
Lead Sponsor | Collaborator |
---|---|
Yeouido St. Mary's Hospital | Samsung Medical Center, Seoul National University Bundang Hospital |
Korea, Republic of,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Bone mineral density | . Percentage change in dual-energy X-ray absorptiometry (DXA) bone mineral density (BMD) at the lumbar spine, total hip, and femoral neck, presented as least square mean and 95% confidence interval. | 1 year | |
Secondary | Bone turnover markers | Percentage change in bone turnover markers [Serum C-telopeptide (CTx) and procollagen type 1 N-terminal propeptide (P1NP) levels were measured by immunoassay methods using Elecsys kits - 07296355001V4 and 07296509001V4 (Roche Diagnostic Corp., Basel, Switzerland) ] presented as adjusted mean and 95% confidence interval using the generalized estimating equations for repeated measures analysis. | 6 month and 12 month |
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