Osteoporosis Clinical Trial
— PROUDOfficial title:
Sustaining Skeletal Health in Frail Elderly
Verified date | October 2023 |
Source | University of Pittsburgh |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 201 |
Est. completion date | August 2023 |
Est. primary completion date | August 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 65 Years and older |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
United States | UPMC Senior Communities | Pittsburgh | Pennsylvania |
Lead Sponsor | Collaborator |
---|---|
Susan L. Greenspan | National Institute on Aging (NIA), National Institutes of Health (NIH) |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Bone density of the total hip | Bone Mineral Density (BMD) of the total hip at 24 months as assessed by dual-energy x-ray absorptiometry (DXA) | 24 months | |
Primary | Bone density of the spine | Bone Mineral Density (BMD) of the spine at 24 months as assessed by dual-energy x-ray absorptiometry (DXA) | 24 months | |
Primary | Extension - Zoledronic Acid Infusion Safety Treatment: Bone density of the total hip | Bone Mineral Density (BMD) of the total hip at 33 months as assessed by dual-energy x-ray absorptiometry (DXA) | 33 months | |
Primary | Extension - Zoledronic Acid Infusion Safety Treatment: Bone density of the total hip | Bone Mineral Density (BMD) of the total hip at 39 months as assessed by dual-energy x-ray absorptiometry (DXA) | 39 months | |
Primary | Extension - Zoledronic Acid Infusion Safety Treatment: Bone density of the spine | Bone Mineral Density (BMD) of the spine at 33 months as assessed by dual-energy x-ray absorptiometry (DXA) | 33 months | |
Primary | Extension - Zoledronic Acid Infusion Safety Treatment: Bone density of the spine | Bone Mineral Density (BMD) of the spine at 39 months as assessed by dual-energy x-ray absorptiometry (DXA) | 39 months |
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