Efficacy in Reducing Fractures and Safety of Zoledronic Acid in Men With Osteoporosis

Novartis Pharmaceuticals1,199 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

1,199

Conditions

Male Osteoporosis

Interventions

Zoledronic acid 5 mg ivDRUG

Zoledronic acid 5 mg iv given once a year.

PlaceboDRUG

Placebo intravenous (i.v.) once a year

Eligibility

Sex: MALEMin age: 50 YearsMax age: 85 Years

Medical Language ↔ Plain English

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

Locations (128)

Outcomes

Primary Outcomes

Percentage of Participants With at Least One New Morphometric Vertebral Fracture Over 24 Months

Vertebral fracture (VF) was assessed based on morphometry. QM(quantitative morphometry) incident VF(QM positive) is defined by at least 20% decrease in vertebral height of at least 4mm. If participant had QM positive at any vertebrae at any visit, x-rays from visits for participants were evaluated using Genant semi-quantitative method for VF assessment: Grade1 Mild VF is defined as 20-24% decrease in anterior, middle, and/or posterior vertebral height. Grade2 moderate VF is defined as 25-40% decrease in vertebral height. Grade3 Severe VF is defined as more than 40% decrease in vertebral height

Time frame: 24 Months

Secondary Outcomes

Percentage of Participants With at Least One New Morphometric Vertebral Fracture Over 12 Months

Time frame: 12 Months

Percentage of Participants With at Least One New Moderate or Severe Morphometric Vertebral Fracture Over 12 Months

Moderate or severe vertebral fracture (VF) was assessed based on morphometry. A QM (quantitative morphometry) incident VF(QM positive) was defined by at least a 20% decrease in any vertebral height (at least 4 mm). If a participant had a QM positive at any vertebrae at any visit,x-rays from all visits for participants were evaluated using Genant semi-quantitative (SQ) method for VF assessment. Grade 2 moderate VF was defined as a 25-40% reduction in any vertebral height.Grade 3 Severe: VF was defined as more than 40% reduction in any vertebral height.

Time frame: 12 months

Data from ClinicalTrials.gov

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Novartis Investigative Site

Buenos Aires, Argentina

Novartis Investigative Site

Córdoba, Argentina

Novartis Investigative Site

Mar del Plata, Argentina

Novartis Investigative Site

San Miguel de Tucumán, Argentina

Novartis Investigative Site

Geelong-VIC, Australia

Novartis Investigative Site

Maroochydore-QLD, Australia

Novartis Investigative Site

Randwick-NSW, Australia

Novartis Investigative Site

Graz, Austria

Novartis Investigative Site

Vienna, Austria

Novartis Investigative Site

Brussels, Belgium

...and 118 more locations

Percentage of Participants With at Least One New Moderate or Severe Morphometric Vertebral Fracture Over 24 Months

Time frame: 24 Months

Percentage of Participants With at Least One New or Worsening Morphometric Vertebral Fracture Over 12 Months

Worsening vertebral fracture (VF) was assessed based on morphometry. QM (quantitative morphometry) incident VF(QM positive) was defined by at least a 20% decrease in any vertebral height (at least 4 mm). If a participant had a QM positive at any vertebrae at any visit, x-rays from all visits for participants were evaluated using Genant semi-quantitative (SQ) method for VF assessment. A worsening fracture was defined as an SQ reading that was greater than the baseline SQ reading, which was at least 1 (prevalent fracture)

Time frame: Baseline, 12 months

Percentage of Participants With at Least One New or Worsening Morphometric Vertebral Fracture Over 24 Months

Worsening vertebral fracture (VF) was assessed based on morphometry. A QM (quantitative morphometry) incident VF(QM positive) was defined by at least a 20% decrease in any vertebral height (at least 4 mm). If a participant had a QM positive at any vertebrae at any visit,x-rays from all visits for participants were evaluated using Genant semi-quantitative (SQ) method for VF assessment. A worsening fracture was defined as an SQ reading that was greater than the baseline SQ reading, which was at least 1 (prevalent fracture)

Time frame: Baseline, Month 24

Mean Change in Height From Baseline

Height was measured using a stadiometer. Two measurements were taken in millimeters (mm), and repeated if the two measurements differed by greater than 4 mm. The average of the two (or four) height measurements was used for analysis

Time frame: from Baseline to 12 months and 24 months

Number of Participants With First Clinical Vertebral Fracture

Clinical vertebral fracture is a painful vertebral fracture which came to clinical attention, e.g., with increased back pain, impairment of mobility or functional limitations. Subjects who did not experience a fracture event were censored at the end of study. End of study was defined as the last visit or date of death, whichever was earlier.

Time frame: 24 months

Number of Participants With First Clinical Fracture

Clinical fracture is painful fracture in any site which came to clinical attention, e.g., with increased pain, impaired mobility or functional limitations. Subjects who did not experience fracture were censored at end of study. End of study was defined as the earlier of last visit or date of death.

Time frame: 24 months

Number of Participants With First Non-vertebral Fracture

Non-vertebral fracture is any fracture which was not of the vertebrae. Subjects who did not experience a fracture event were censored at the end of study. End of study was defined as the last visit or date of death, whichever was earlier.

Time frame: 24 months

Percentage Change From Baseline in Lumbar Spine Bone Mass Density (BMD)

Dual energy x-ray absorptiometry (DXA) Least Square Means (LSM) were analyzed using an ANCOVA model with treatment and baseline value as explanatory variables. Percent change in BMD at lumbar spine at Months 6, 12, and 24 relative to baseline as measured by DXA in a subset of at least 100 evaluable subjects at selected sites. Percentage change from baseline = 100\*(endpoint - baseline)

Time frame: Month 6, Month 12, Month 24

Percentage Change From Baseline in Total Hip BMD (g/CM^2)

Dual energy x-ray absorptiometry (DXA) Least Square Means (LSM) were analyzed using an ANCOVA model with treatment and baseline value as explanatory variables. Percent change in total hip BMD at Months 6, 12, and 24 relative to baseline as measured by DXA in a subset of at least 100 evaluable subjects at selected sites. Percentage change from baseline = 100\*(endpoint - baseline)

Time frame: Month 6, Month 12, Month 24

Percentage Change From Baseline in Femoral Neck BMD (g/CM^2)

Dual energy x-ray absorptiometry (DXA) Least Square Means (LSM) were analyzed using an ANCOVA model with treatment and baseline value as explanatory variables. Percent change in total femoral neck BMD at Months 6, 12, and 24 relative to baseline as measured by DXA in a subset of at least 100 evaluable subjects at selected sites. Percentage change from baseline = 100\*(endpoint - baseline)

Time frame: Month 6, Month 12, Month 24

Serum Beta C-terminal Telopeptides of Type I Collagen(b-CTx) by Visits

Time frame: Baseline, Month 3, Month 6, Month 12, Month 15, month 18, Month 24