The National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) supports a range of clinical trials studying new and existing interventions for prevention and treatment of arthritis, musculoskeletal, and skin diseases. This trial is complete, and results are now available.
Click on Main Page to learn more about actively recruiting research studies for which you or someone you know may be eligible.
Ongoing studies that have completed recruitment are found here.
Study Description
Osteoporosis is unique among chronic conditions in that there is no accepted role for combining medications, even in patients who are at the highest risk of fracture. Both anabolic and antiresorptive osteoporosis therapies increase bone density and reduce fracture incidence but are unable to restore skeletal integrity in most patients with established disease. Attempts to combine the only available anabolic agent (teriparatide) with the most commonly used antiresorptive agents (bisphosphonates) have demonstrated no benefit compared to each drug alone. Conversely, the study team recently reported that the combination of teriparatide and the nuclear factor-κB ligand inhibitor, denosumab, increases bone density, and improves cortical microarchitecture more than each drug alone. This combination shows superior efficacy, at least in part, because denosumab is able to fully block teriparatide's pro-resorptive effects while allowing for continued bone formation. Thus, combining denosumab with a more potent anabolic stimulus may allow for greater separation of formation and resorption and larger improvements in bone mass and strength.
The aim of the current study is to evaluate a rational and cost-effective approach to this consolidation by testing the hypotheses that in postmenopausal women with osteoporosis, the large increases in bone density and improvements in bone quality achieved with combined denosumab/teriparatide therapy will be maintained and extended by a single administration of an intravenous bisphosphonate.
ELIGIBILITY CRITERIA:
Ages Eligible for Study: 45 Years and older (Adult, Older Adult)
Sexes Eligible for Study: Female
Accepts Healthy Volunteers: Yes
Inclusion Criteria:
- women aged 45+
- postmenopausal
- osteoporotic with high risk of fracture
Exclusion Criteria:
- no significant previous use of bone health modifying treatments
Study Design:
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Study Location(s):
Massachusetts General Hospital, Boston, Massachusetts, United States, 02114
Study Website:
https://clinicaltrials.gov/ct2/show/NCT02176382?term=NCT02176382&draw=2&rank=1