preventing osteoporosis using denosumab

Conditions: Osteoporosis, Postmenopausal; Osteoporosis; Osteoporotic Fractures

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.

objective: the long term goal is to improve health, well-being and quality of life in the frail long-term care (ltc) elderly population by reducing fractures. the short term goal is to demonstrate efficacy of the non-bisphosphonate denosumab to improve bone mineral density (bmd), a necessary (but not sufficient) pre-condition of a large fracture reduction trial. the investigators propose to conduct a 2-year, randomized, double-blind, calcium-vitamin d controlled trial to test the efficacy and predictability of the antiresorptive rank ligand inhibitor, denosumab (60 mg), among a cohort of 212 institutionalized, under-served, frail men and women ≥65 years old in ltc. specific aims: aim 1: to evaluate efficacy of denosumab in improving/maintaining bone mineral density. the investigators will measure conventional hip and spine bone mineral density (bmd). primary hypothesis: after 2 years, women and men on denosumab will have greater hip and spine bmd increases.

Eligibility criteria:
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 d level is not at least 25 ng/ml, they will not be eligible to be randomized into the study). * those on dialysis or with stage 5 chronic kidney disease (egfr\<15ml/min) will be excluded at screening. * those requiring tooth extraction or oral surgery will not be enrolled until cleared by a dentist. * patients will be allowed to continue on glucocorticoids and anticonvulsants because their use is common in this population. * those on glucocorticoids and anticonvulsants will be allowed to continue in the study because their use is common in this population. * those on hormone replacement therapy (hrt), raloxifene, or prescribed protective hip pads by their primary care physician (pcp) will be allowed to participate and continue on these therapies. * we will suggest that participants stop long-term calcitonin as it has been discontinued in europe due to cancer concerns.

Keywords: bone loss frail geriatric patients nursing home patients long-term care patients osteoporosis osteoporotic fractures