Preventing Osteoporosis Using Denosumab (PROUD)

This is an interventional treatment trial for Osteoporosis, Postmenopausal focused on measuring Bone loss, Frail Geriatric Patients, Nursing Home Patients, Long-term Care Patients, Osteoporosis, Osteoporotic Fractures Read More

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.