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Zoledronic Acid in the Prevention of Bone Loss in Postmenopausal Women With Osteopenia, 45 Years of Age and Older

Primary Purpose

Osteopenia

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Zoledronic Acid
Placebo
Sponsored by
Novartis Pharmaceuticals
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Osteopenia focused on measuring Postmenopausal osteoporosis, osteopenia, zoledronic acid, Osteopenia (osteoporosis prevention)

Eligibility Criteria

45 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria: Postmenopausal Greater than or equal to 45 years of age Osteopenia (lumbar spine bone mineral density [BMD] T-score between -1.0 and -2.5, and BMD T-score > -2.5 at the femoral neck) Exclusion Criteria: Patients with more than one Grade 1 vertebral fracture (as per Genant method; patients with one Grade 1 vertebral fracture are eligible to participate) Patients with any Grade 2 or 3 vertebral fracture (as per Genant method) Patients with 25-(OH) vitamin D levels less than 15 ng/mL prior to randomization Other protocol-defined inclusion/exclusion criteria may apply.

Sites / Locations

  • For information regarding facilities, please contact the Central Contact

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Placebo Comparator

Arm Label

Zoledronic Acid 2x5 mg

Zoledronic Acid 1x5 mg

Placebo

Arm Description

Zoledronic acid 5 mg intravenous (i.v.) given at randomization and Month 12

Zoledronic acid 5 mg intravenous (i.v.) given at randomization and placebo at Month 12

Placebo given at randomization and Month 12

Outcomes

Primary Outcome Measures

Percentage Change in Lumbar Spine Bone Mineral Density (BMD) at Month 24 Relative to Baseline, by Stratum
The percentage change in lumbar spine BMD at Month 24 relative to baseline was derived as 100 x (lumbar spine BMD at 24 Month - lumbar spine BMD at baseline) / (lumbar spine BMD at baseline).

Secondary Outcome Measures

Percentage Change in Total Hip BMD at Month 24 Relative to Baseline, by Stratum.
The percentage change in total hip BMD at Month 24 relative to baseline was derived as 100 x (total hip BMD at 24 Month - total hip BMD at baseline) / (total hip BMD at baseline).
Percentage Change in Femoral Neck BMD at Month 24 Relative to Baseline, by Stratum.
The percentage change in femoral neck BMD at Month 24 relative to baseline was derived as 100 x (femoral neck BMD at 24 Month - femoral neck BMD at baseline) / (femoral neck BMD at baseline).
Biochemical Marker of Bone Resorption: Serum Beta C-telopeptides (b-CTx), by Stratum
Biomarker: Serum b-CTx levels at Months 6, 12, 18 and 24 by stratum.
Biochemical Marker of Bone Formation: Serum N-terminal Propeptide of Type 1 Collagen (P1NP), by Stratum
Biomarker: Serum P1NP levels at Months 6, 12, 18 and 24 by stratum.
Biochemical Marker of Bone Formation: Bone Serum Alkaline Phosphatase (BSAP), by Stratum
Biomarker: BSAP levels at Months 6, 12, 18 and 24 by stratum.

Full Information

First Posted
August 18, 2005
Last Updated
August 1, 2016
Sponsor
Novartis Pharmaceuticals
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1. Study Identification

Unique Protocol Identification Number
NCT00132808
Brief Title
Zoledronic Acid in the Prevention of Bone Loss in Postmenopausal Women With Osteopenia, 45 Years of Age and Older
Official Title
A 2-year Randomized, Multicenter, Double-blind, Placebo-controlled Study to Determine the Efficacy and Safety of Intravenous Zoledronic Acid 5 mg Administered Either Annually at Randomization and 12 Months, or Administered at Randomization Only in the Prevention of Bone Loss in Postmenopausal Women With Osteopenia
Study Type
Interventional

2. Study Status

Record Verification Date
August 2016
Overall Recruitment Status
Completed
Study Start Date
July 2004 (undefined)
Primary Completion Date
February 2008 (Actual)
Study Completion Date
February 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Novartis Pharmaceuticals

4. Oversight

5. Study Description

Brief Summary
Osteoporosis prevention is important in patients with osteopenia (low bone density). This study will test the safety and efficacy of zoledronic acid in patients diagnosed with osteopenia.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteopenia
Keywords
Postmenopausal osteoporosis, osteopenia, zoledronic acid, Osteopenia (osteoporosis prevention)

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
581 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Zoledronic Acid 2x5 mg
Arm Type
Experimental
Arm Description
Zoledronic acid 5 mg intravenous (i.v.) given at randomization and Month 12
Arm Title
Zoledronic Acid 1x5 mg
Arm Type
Experimental
Arm Description
Zoledronic acid 5 mg intravenous (i.v.) given at randomization and placebo at Month 12
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo given at randomization and Month 12
Intervention Type
Drug
Intervention Name(s)
Zoledronic Acid
Intervention Description
Zoledronic acid 5 mg intravenous
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Physiologic 0.9% normal saline
Primary Outcome Measure Information:
Title
Percentage Change in Lumbar Spine Bone Mineral Density (BMD) at Month 24 Relative to Baseline, by Stratum
Description
The percentage change in lumbar spine BMD at Month 24 relative to baseline was derived as 100 x (lumbar spine BMD at 24 Month - lumbar spine BMD at baseline) / (lumbar spine BMD at baseline).
Time Frame
Baseline, Month 24
Secondary Outcome Measure Information:
Title
Percentage Change in Total Hip BMD at Month 24 Relative to Baseline, by Stratum.
Description
The percentage change in total hip BMD at Month 24 relative to baseline was derived as 100 x (total hip BMD at 24 Month - total hip BMD at baseline) / (total hip BMD at baseline).
Time Frame
Baseline, Month 24
Title
Percentage Change in Femoral Neck BMD at Month 24 Relative to Baseline, by Stratum.
Description
The percentage change in femoral neck BMD at Month 24 relative to baseline was derived as 100 x (femoral neck BMD at 24 Month - femoral neck BMD at baseline) / (femoral neck BMD at baseline).
Time Frame
Baseline, Month 24
Title
Biochemical Marker of Bone Resorption: Serum Beta C-telopeptides (b-CTx), by Stratum
Description
Biomarker: Serum b-CTx levels at Months 6, 12, 18 and 24 by stratum.
Time Frame
Months 6, 12, 18 and 24
Title
Biochemical Marker of Bone Formation: Serum N-terminal Propeptide of Type 1 Collagen (P1NP), by Stratum
Description
Biomarker: Serum P1NP levels at Months 6, 12, 18 and 24 by stratum.
Time Frame
Months 6, 12, 18 and 24
Title
Biochemical Marker of Bone Formation: Bone Serum Alkaline Phosphatase (BSAP), by Stratum
Description
Biomarker: BSAP levels at Months 6, 12, 18 and 24 by stratum.
Time Frame
Months 6, 12, 18 and 24

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Postmenopausal Greater than or equal to 45 years of age Osteopenia (lumbar spine bone mineral density [BMD] T-score between -1.0 and -2.5, and BMD T-score > -2.5 at the femoral neck) Exclusion Criteria: Patients with more than one Grade 1 vertebral fracture (as per Genant method; patients with one Grade 1 vertebral fracture are eligible to participate) Patients with any Grade 2 or 3 vertebral fracture (as per Genant method) Patients with 25-(OH) vitamin D levels less than 15 ng/mL prior to randomization Other protocol-defined inclusion/exclusion criteria may apply.
Facility Information:
Facility Name
For information regarding facilities, please contact the Central Contact
City
E. Hanover
State/Province
New Jersey
ZIP/Postal Code
07936
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
21037195
Citation
Grbic JT, Black DM, Lyles KW, Reid DM, Orwoll E, McClung M, Bucci-Rechtweg C, Su G. The incidence of osteonecrosis of the jaw in patients receiving 5 milligrams of zoledronic acid: data from the health outcomes and reduced incidence with zoledronic acid once yearly clinical trials program. J Am Dent Assoc. 2010 Nov;141(11):1365-70. doi: 10.14219/jada.archive.2010.0082.
Results Reference
derived
PubMed Identifier
20168099
Citation
McClung M, Miller P, Recknor C, Mesenbrink P, Bucci-Rechtweg C, Benhamou CL. Zoledronic acid for the prevention of bone loss in postmenopausal women with low bone mass: a randomized controlled trial. Obstet Gynecol. 2009 Nov;114(5):999-1007. doi: 10.1097/AOG.0b013e3181bdce0a.
Results Reference
derived

Learn more about this trial

Zoledronic Acid in the Prevention of Bone Loss in Postmenopausal Women With Osteopenia, 45 Years of Age and Older

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