Description of Trials
| Intervention Arm | Control Arm | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Trial | Year | Length of Study (in months) | Primary Endpoint of Trial | Patient Baseline Characteristics | Intervention Arm | Control Arm | n | # of Clinical Fractures | # of Osteoporotic Fractures | n | # of Clinical Fractures | # of Osteoporotic Fractures | Location |
| Miller | 2008 | 48 | BMD at total hip, lumbar spine, total hip, distal one-third radius, total body; bone turnover markers (sCTX1 and uNTX), safety | Postmenopausal women up to 80 years (mean age not reported) with T-scores between −1.8 and −4.0 at the lumbar spine or −1.8 and −3.5 at the femoral neck or total hip. | Denosumab 6 mg, 14 mg, or 30 mg Q3 mol/L subcutaneously or denosumab 14 mg, 60 mg, 100 mg, or 210 mg Q6M | Alendronate 70 mg Q1W PO | 319 | 33 | 22 | 47 | 3 | 2 | United States |
| Brown | 2009 | 12 | BMD at total hip, femoral neck, trochanter, lumbar spine, one-third radius; bone turnover markers (sCTX1 and P1NP) | Postmenopausal women (mean age not reported); T‐score ≤ −2.0 at the lumbar spine or total hip | Denosumab 60 mg Q6 mol/L SC | Alendronate 70 mg Q1W PO | 594 | 6 | 18 | 595 | 6 | 13 | International |
| Kendler | 2010 | 12 | Percent change in total hip BMD from baseline to month 12 | Postmenopausal women ≥ 55 years (mean age not reported) with a T‐score between −4 and −2 at lumbar spine or total hip and who had been receiving alendronate treatment equivalent to 70 mg/week ≥ 6 months | Denosumab 60 mg Q6 mol/L SC | Alendronate 70 mg Q1W PO | 253 | 8 | 2 | 249 | 4 | 0 | International |
| Freemantle | 2012 | 12 | Medication adherence (compliance and persistence) | Postmenopausal women aged ≥ 55 years (mean age not reported) with T-scores between −4 and −2 at femoral neck, lumbar spine, or total hip | Denosumab 60 mg Q6 mol/L SC | Alendronate 70 mg Q1W PO | 126 | 1 | 0 | 124 | 1 | 0 | International |
| Recknor | 2013 | 12 | Percentage change from baseline in BMD at total hip, femoral neck, lumbar spine; percentage change from baseline in sCTX1 | Postmenopausal women aged ≥55 years (mean age not reported) who were previously prescribed bisphosphonate therapy but had either stopped taking it by the time of the study screening visit or were still taking it with low adherence; T-score of −2 or less and −4 or greater at the total hip or lumbar spine determined at the local site and had one or more proximal femur (hip) and two or more vertebrae between L1 and L4 | Denosumab 60 mg Q6 mol/L SC | Ibandronate 150 mg Q1 mol/L PO | 417 | 13 | 2 | 416 | 10 | 3 | International |
| Roux | 2014 | 12 | Percentage change from baseline in BMD at total hip, femoral neck, lumbar spine; percentage change from baseline in sCTX1 | Postmenopausal women aged ≥55 years (mean age not reported) who were previously prescribed alendronate therapy but had either stopped taking it by the time of the study screening visit or were still taking it with low adherence | Denosumab 60 mg Q6 mol/L SC | Risedronate 150 mg Q1 mol/L PO | 435 | 19 | 6 | 435 | 15 | 2 | International |
| Miller | 2016 | 24 | Mean percentage change from baseline in lumbar spine BMD | Postmenopausal women ≥ 55 years (mean age not reported) who received oral bisphosphonate therapy for ≥2 years immediately before screening; T-score of ≤ −2.5 at the lumbar spine, total hip, or femoral neck | Denosumab 60 mg Q6 mol/L SC | Zoledronic acid 5 mg Q12 mol/L IV | 313 | 11 | 7 | 312 | 18 | 15 | International |
P1NP = N-terminal propeptide of type 1 collagen; sCTX1, serum carboxy-terminal collagen crosslinks; uNTX, urinary N-telopeptide cross-links.