Activity of Pre-Osteoclasts and Osteoclasts Over Time in Postmenopausal Women Treated With Denosumab or Zoledronic Acid

Withdrawn before enrolling

Conditions studied: Osteoporosis, Postmenopausal

In brief

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 associated with changes in bone mass.

Key facts

Study ID

NCT03812367

Run by

University of California, Davis

People needed

0

Starts

2019-01-01

Expected to finish

2021-12-31

Last updated by the study team

2019-06-14

Who can join

Age: 50 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• UC Davis Health, Center for Musculoskeletal Health — Sacramento, California, United States

Full record on ClinicalTrials.gov

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