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This study examines how suppressing osteoclasts (the cells that break down bone) affects bone formation, comparing the drug Denosumab with placebo. Healthy premenopausal women aged 25 to 40 and postmenopausal women aged 60 to 80 may take part. The study was conducted in Early Phase 1 and has been completed.
The summary above is a plain-language rendering of the official record. The original English title is shown for reference.
Criteria are reproduced from the ClinicalTrials.gov record in the original English. Only the trial team can determine eligibility.
* Inclusion Criteria: * normal premenopausal women aged 25-40 years * normal postmenopausal women aged 60-80 years * at least 5 yrs since their last menses * follicle stimulating hormone (FSH) \> 20 IU/L * Exclusion Criteria: * Abnormality in any of the screening laboratory studies * Presence of significant liver or renal disease * Malignancy (including myeloma) * Malabsorption * Diabetes * Hypoparathyroidism * Hyperparathyroidism * Acromegaly * Cushing's syndrome * Hypopituitarism * Severe chronic obstructive pulmonary disease * Undergoing treatment with any medications that affect bone turnover, including the following: * adrenocorticosteroids (\> 3 months at any time or \> 10 days within the previous yr) * anticonvulsant therapy (within the previous year) * pharmacological doses of thyroid hormone (causing decline of thyroid stimulating hormone below normal) * calcium supplementation of \> 1200 mg/d (within the preceding 3 months) * bisphosphonates (within the past 3 yrs) * denosumab * estrogen (E) therapy within the past year * treatment with a selective E receptor modulator within the past year * teriparatide within the past yr * Clinical history of osteoporotic fracture (vertebral, hip, or distal forearm) * Recent (within the past 6 months) fracture * Serum 25-hydroxyvitamin D levels of \< 20 ng/ml