Trial record 4 of 195 for:    Open Studies | "Osteoporosis"

Preventing Osteoporosis Using Denosumab (PROUD)

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2016 by University of Pittsburgh
Sponsor:
Collaborators:
National Institutes of Health (NIH)
National Institute on Aging (NIA)
Information provided by (Responsible Party):
Susan L. Greenspan, University of Pittsburgh
ClinicalTrials.gov Identifier:
NCT02753283
First received: April 25, 2016
Last updated: June 22, 2016
Last verified: June 2016
  Purpose
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.

Condition Intervention Phase
Osteoporosis, Postmenopausal
Osteoporosis
Osteoporotic Fractures
Drug: denosumab
Drug: Placebo
Dietary Supplement: Calcium and Vitamin D
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: Sustaining Skeletal Health in Frail Elderly

Resource links provided by NLM:


Further study details as provided by University of Pittsburgh:

Primary Outcome Measures:
  • Increased bone density of the total hip [ Time Frame: 24 months ] [ Designated as safety issue: No ]
    Bone Mineral Density (BMD) of the total hip at 24 months as assessed by dual-energy x-ray absorptiometry (DXA)

  • Increased bone density of the spine [ Time Frame: 24 months ] [ Designated as safety issue: No ]
    Bone Mineral Density (BMD) of the spine at 24 months as assessed by dual-energy x-ray absorptiometry (DXA)


Estimated Enrollment: 212
Study Start Date: June 2016
Estimated Study Completion Date: December 2021
Estimated Primary Completion Date: December 2021 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Active Medication Group
Semi-annual dose: denosumab 60 mg semi-annual injection; Vitamin D 800-1000 IU/daily and Calcium 1200 mg/daily (dietary + supplements)
Drug: denosumab
Semi-annual dose: 60 mg injection; Vitamin D 800-1000 IU/daily and Calcium 1200 mg/daily (dietary + supplement)
Other Name: Prolia
Dietary Supplement: Calcium and Vitamin D
Dietary supplement: vitamin D 800-1000 IU/daily and calcium 1200 mg/daily (dietary + supplement)
Placebo Comparator: Placebo Group
Semi-annual: placebo saline injection; Vitamin D 800-1000 IU/daily and Calcium 1200 mg/daily (dietary + supplements)
Drug: Placebo
Semi-annual saline injection
Dietary Supplement: Calcium and Vitamin D
Dietary supplement: vitamin D 800-1000 IU/daily and calcium 1200 mg/daily (dietary + supplement)

Detailed Description:

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.

Aim 2: To examine improvements in trabecular microstructure and collect preliminary exploratory evidence on fractures for a subsequent fracture reduction trial. The investigators will measure vertebral trabecular bone score (TBS), a 3-D microarchitectural image and parameters of the spine independent of BMD.

Hypothesis 2: After 2 years, participants on denosumab will have greater increases in TBS measures.

Aim 3: To determine characteristics associated with responders and non-responders. The investigators will use multiple regression analyses and other data mining techniques to identify baseline characteristics of responders and non-responders.

Hypothesis 3.1: Poor baseline functional/cognitive status/immobility will be associated with poor bone health outcomes.

Hypothesis 3.2: Greater early changes in bone turnover markers will be associated with greater skeletal improvements.

  Eligibility

Ages Eligible for Study:   65 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02753283

Contacts
Contact: Kara Armbruster, RN, BSN 412-692-2477 klb189@pitt.edu
Contact: Dory Adams, MFA 412-692-2480 dja21@pitt.edu

Locations
United States, Pennsylvania
UPMC Senior Communities Recruiting
Pittsburgh, Pennsylvania, United States, 15213
Contact: Daniel Grant         
Sponsors and Collaborators
University of Pittsburgh
National Institutes of Health (NIH)
National Institute on Aging (NIA)
Investigators
Principal Investigator: Susan L Greenspan, MD University of Pittsburgh
  More Information

Responsible Party: Susan L. Greenspan, Professor of Medicine, University of Pittsburgh
ClinicalTrials.gov Identifier: NCT02753283     History of Changes
Other Study ID Numbers: PRO15110448  1R01AG052123-01 
Study First Received: April 25, 2016
Last Updated: June 22, 2016
Health Authority: United States: Data and Safety Monitoring Board
United States: Institutional Review Board
Individual Participant Data  
Plan to Share IPD: No

Keywords provided by University of Pittsburgh:
Bone loss
Frail Geriatric Patients
Nursing Home Patients
Long-term Care Patients
Osteoporosis
Osteoporotic Fractures

Additional relevant MeSH terms:
Osteoporosis
Osteoporosis, Postmenopausal
Osteoporotic Fractures
Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases
Fractures, Bone
Wounds and Injuries
Vitamins
Vitamin D
Ergocalciferols
Calcium, Dietary
Denosumab
Micronutrients
Growth Substances
Physiological Effects of Drugs
Bone Density Conservation Agents

ClinicalTrials.gov processed this record on August 29, 2016