Combination therapy improves site-specific BMD vs. teriparatide & denosumab monotherapies

Study Type: Therapy
OE Level of Evidence: 2
Journal Level of Evidence: N/A
Synopsis
94 postmenopausal osteoporotic women were randomized to receive either 60mg denosumab subcutaneously every 6 months, 20ug teriparatide subcutaneously daily, or a combination treatment of both 60mg denosumab and 20ug teriparatide for a duration of 24 months. The purpose of this study was to compare the individual response rates of the three treatment groups in terms of increases in bone mineral density (BMD) at the total hip, femoral neck, lumbar spine, and distal one-third radius shaft. Outcomes were assessed Please login to view the rest of this report. Please login to view the rest of this report.
Funding: Industry funded
Sponsor: Eli Lilly Inc. and Amgen Inc.
Conflicts: None disclosed
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Why was this study needed now?
Common treatments used to manage osteoporosis include teriparatide, an osteoanabolic agent, or denosumab, an antiresorptive agent. These treatments have been reported to increase spine and hip bone mineral density (BMD) and reduce the risk of fractures. The previously conducted DATA study demonstrated a greater increase in BMD in combining both treatments compared to either treatment alone. The present follow-up study was conducted to determine whether such results could be reproduced in individual response rates at the total hip, femoral neck, lumbar spine, and distal 1/3 radius.
What was the principal research question?
In the treatment of postmenopausal women with osteoporosis or osteopenia, is there a greater efficacy in combination therapy compared to monotherapy of either denosumab 60mg or teriparatide 20ug with regards to individual response rates, defined as a minimum increase in bone mineral density of 3% at the hip, femoral neck, lumbar spine, and distal 1/3 radius, assessed up to 24 months.
Population: 94 postmenopausal women, aged 45 years or older, with either osteoporosis (T-score <-2.5), or osteopenia (T-score -1.0 to -2.5) and associated fracture risk factor or history of fragility fracture. All patients were administered calcium carbonate and vitamin D supplements to reach an intake level of 1200mg elemental calcium and >20 ng/mL serum 25-hydroxyvitamin level.
Intervention: Combination therapy group: patients received a combination of 60mg denosumab (Prolia; Amgen, Inc., Thousand Oaks, CA) subcutaneously every 6 months and 20ug teriparatide (FORTEO; Eli Lilly Inc., Indianapolis IN) subcutaneously daily for a duration of 24 months. (24 completed 24-month follow-up; Mean age: 65.1+/-7.9)
Comparison: Denosumab group: patients received 60mg denosumab (Prolia; Amgen, Inc., Thousand Oaks, CA) subcutaneously every 6 months (30 completed 24-month follow-up; Mean age: 65.1+/-6.2) Teriparatide group: patients received 20ug teriparatide (FORTEO; Eli Lilly Inc., Indianapolis IN) subcutaneously daily (28 completed 24-month follow-up; Mean age: 65.6+/-8.3)
Outcomes: The primary outcome of this study were individual rates of "response" to treatment, defined as a minimum increase in areal bone mineral density (BMD) of the posterior-anterior lumbar spine, total hip, femoral neck. and distal 1/3 radial shaft of at least 3% on dual-energy X-ray absorptiometry (DXA). Additional analysis was performed considering "excellent responder" criteria (minimum 6% increase BMD).
Methods: RCT; response study to the initial Denosumab and Teriparatide Administration (DATA) study.
Time: Follow-up scheduled for 3, 6, 12, 18, and 24 month
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How will this affect the care of my patients?
The authors responsible for this critical appraisal and ACE Report indicate no potential conflicts of interest relating to the content in the original publication.