Phase 3
N=1,199
Efficacy in Reducing Fractures and Safety of Zoledronic Acid in Men With Osteoporosis
Male Osteoporosis
Bottom Line
View on ClinicalTrials.gov: NCT00439647 ↗Enrolled (actual)
1,199
Serious AEs
25.3%
Results posted
Nov 2011
Primary outcome: Primary: Percentage of Participants With at Least One New Morphometric Vertebral Fracture Over 24 Months — 1.6; 4.9 Percentage of Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Zoledronic acid 5 mg iv (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 50+ yrs
- Sex
- Male
- Sponsor
- Novartis Pharmaceuticals
- Primary completion
- Oct 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With at Least One New Morphometric Vertebral Fracture Over 24 Months |
1.6; 4.9 | — |
| SECONDARY Percentage of Participants With at Least One New Morphometric Vertebral Fracture Over 12 Months |
0.9; 2.8 | — |
| SECONDARY Percentage of Participants With at Least One New Moderate or Severe Morphometric Vertebral Fracture Over 12 Months |
0.4; 1.9 | — |
| SECONDARY Percentage of Participants With at Least One New Moderate or Severe Morphometric Vertebral Fracture Over 24 Months |
1.1; 3.0 | — |
| SECONDARY Percentage of Participants With at Least One New or Worsening Morphometric Vertebral Fracture Over 12 Months |
1.3; 2.8 | — |
| SECONDARY Percentage of Participants With at Least One New or Worsening Morphometric Vertebral Fracture Over 24 Months |
2.0; 4.9 | — |
| SECONDARY Mean Change in Height From Baseline |
-0.86; -2.50; -2.33; -4.61 | — |
| SECONDARY Number of Participants With First Clinical Vertebral Fracture |
1; 3 | — |
| SECONDARY Number of Participants With First Clinical Fracture |
6; 11 | — |
| SECONDARY Number of Participants With First Non-vertebral Fracture |
5; 8 | — |
| SECONDARY Percentage Change From Baseline in Lumbar Spine Bone Mass Density (BMD) |
4.87; 0.10; 5.51; 0.84; 7.73; 1.61 | — |
| SECONDARY Percentage Change From Baseline in Total Hip BMD (g/CM^2) |
1.38; -0.44; 1.66; 0.26; 2.31; 0.16 | — |
| SECONDARY Percentage Change From Baseline in Femoral Neck BMD (g/CM^2) |
2.21; 0.58; 2.06; 0.59; 3.39; 0.09 | — |
| SECONDARY Serum Beta C-terminal Telopeptides of Type I Collagen(b-CTx) by Visits |
0.3646; 0.3933; 0.0990; 0.3647; 0.1384; 0.3540 | — |
Summary
This study will investigate if the drug zoledronic acid given once yearly is safe and has beneficial effects in treating osteoporosis by reducing bone loss and fractures in men with osteoporosis.
Eligibility Criteria
Inclusion Criteria
- Osteoporosis as defined by very low bone mineral density in the hip and spine or low bone mineral density in the hip combined with presence of 1-3 mild or moderate fractures of the vertebrae
Exclusion Criteria
- Low Vitamin D
- Renal insufficiency
- Previous treatment with certain anti-osteoporotic therapies (except after certain washout periods): calcitonin, bisphosphonates, parathyroid hormone (PTH), sodium fluoride, strontium ranelate,
- Previous treatment with testosterone, anabolic steroids or growth hormone
- Chronic use of systemic corticosteroids (oral or i.v.) within the last year
- History of any cancer or metastases within the last 5 years
- History of brittle bone disease, multiple myeloma, or Paget's disease, or any other metabolic bone disease, except osteoporosis
- Bilateral hip replacements
Other protocol-defined inclusion/exclusion criteria may apply
Data sourced from ClinicalTrials.gov (NCT00439647). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.