Status:
WITHDRAWN
Activity of Pre-Osteoclasts and Osteoclasts Over Time in Postmenopausal Women Treated With Denosumab or Zoledronic Acid
Lead Sponsor:
University of California, Davis
Collaborating Sponsors:
Amgen
Conditions:
Osteoporosis, Postmenopausal
Eligibility:
FEMALE
50+ years
Brief Summary
This study evaluates how patients treated with denosumab or zoledronic acid for osteoporosis may change the number of peripheral osteoclast precursors and osteoclast activity, and how that may be asso...
Detailed Description
Postmenopausal osteoporosis is the leading cause of low trauma fractures. At the time of menopause there is an uncoupling of bone turnover, with osteoclast mediated bone resorption increased more than...
Eligibility Criteria
Inclusion
- Women at least 50 years of age who are postmenopausal. Postmenopausal is defined as being amenorrheic for at a period of at least 12 months.
- Diagnosis of osteoporosis by T score of \< -2.5 at either lumbar spine or the hip/femoral neck, or osteopenia that qualifies for treatment by FRAX calculation (10-year risk of hip fracture \> 3% and/or major osteoporotic fracture of \> 20%).
- 3a. Subjects who have had chronic treatment of denosumab (as defined as \> 1 year \[at least 3 6-monthly injections\]) or zoledronic acid (defined as ≥ 2 years \[at least 2 annual injections\]) . Note: At the time of treatment initiation, subjects must have met criteria for on-label use (e.g. criterion 2 above).
- OR 3b. Subjects who are naïve to treatment with denosumab and/or zoledronic acid.
Exclusion
- Renal insufficiency, with glomerular filtration rate (GFR) \< 35 ml/min.
- Hypocalcemia within 6 months of study initiation.
- Known hypersensitivity to denosumab or zoledronic acid.
- Medications that could alter bone turnover including prednisone, anti-rheumatic medications, anti-metabolites (Cytoxan). Subjects who have been on stable doses of thyroid replacement or diabetes medications for more than 3 months are eligible.
- Evidence of untreated oral cavities or oral infections. Preventative dental exams should be performed before starting denosumab or zoledronic acid. Subjects must avoid invasive dental procedures during treatment with denosumab or zoledronic acid.
Key Trial Info
Start Date :
January 1 2019
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
December 31 2021
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT03812367
Start Date
January 1 2019
End Date
December 31 2021
Last Update
June 14 2019
Active Locations (1)
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1
UC Davis Health, Center for Musculoskeletal Health
Sacramento, California, United States, 95817