Preventing Osteoporosis Using Denosumab (NCT02753283) | Clinical Trial Compass
CompletedPhase 4
Preventing Osteoporosis Using Denosumab
United States201 participantsStarted 2016-06
Plain-language summary
The purpose of this research study is to find out if denosumab (Prolia®), an injection given in the arm under the skin every 6 months, works to treat bone loss and prevent it from worsening in older men and women (ages 65 and older) who have osteoporosis and reside in long-term care (LTC) facilities.
Who can participate
Age range65 Years
SexALL
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Inclusion Criteria:
Ambulatory male and female residents with osteoporosis or low bone mass (at risk for fracture) ages 65 and older will be considered if:
* Reside in long-term care institution (nursing home or assisted living facility); and
* HaveOsteoporosis: (1) by bone density \[spine, hip or forearm Bone Mineral Density (BMD) T-score ≤ -2.5\]; (2) A previous adult fragility fracture of the spine or hip; or (3) Would be treated based on FRAX® and the National Osteoporosis Foundation (NOF) treatment thresholds of a 10 year risk of ≥ 20% for a major fracture or ≥ 3% for hip fracture suing femoral neck BMD.
Exclusion Criteria:
* Institutionalized residents with subacute illnesses who are not expected to survive or who will be discharged in \< 2 years.
* Non-ambulatory residents (those who cannot stand and pivot with assistance in order to transfer to the DXA table).
* Those currently on therapy (including bisphosphonate, denosumab, or teriparatide) or who have been on a bisphosphonate for \> 1year during the previous 2 years because some bisphosphonates are long acting.
* Those with a history of hypocalcemia or contraindication for treatment. We will screen for these conditions by detailed history, chart review, and baseline laboratory analyses.
* Those with vitamin D levels \< 25ng/mL will be treated with vitamin D 50,000 IU/wk for 8 weeks; they will be enrolled if the follow-up vitamin D level is 25 ng/mL or more (if after 2 rounds of vitamin D repletion their vitamin…