Preventing Osteoporosis Using Denosumab

• Status: Active, not recruiting
• Trial end date: 2023-09-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Susan L. Greenspan; University of Pittsburgh
• Collaborators: National Institute on Aging (NIA); National Institutes of Health (NIH)
• Treatments: Calcium; Calcium, Dietary; Denosumab; Ergocalciferols; Vitamin D; Vitamins; Zoledronic Acid

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.