NCT00132808

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
581

participants targeted

Target at P75+ for phase_3

Timeline
Completed

Started Jul 2004

Typical duration for phase_3

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2004

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

August 18, 2005

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 22, 2005

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2008

Completed
2.9 years until next milestone

Results Posted

Study results publicly available

January 10, 2011

Completed
Last Updated

September 12, 2016

Status Verified

August 1, 2016

Enrollment Period

3.6 years

First QC Date

August 18, 2005

Results QC Date

December 10, 2010

Last Update Submit

August 1, 2016

Conditions

Osteopenia

Keywords

Postmenopausal osteoporosisosteopeniazoledronic acidOsteopenia (osteoporosis prevention)

Outcome Measures

Primary Outcomes (1)

  • 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).

    Baseline, Month 24

Secondary Outcomes (5)

  • Percentage Change in Total Hip BMD at Month 24 Relative to Baseline, by Stratum.

    Baseline, Month 24

  • Percentage Change in Femoral Neck BMD at Month 24 Relative to Baseline, by Stratum.

    Baseline, Month 24

  • Biochemical Marker of Bone Resorption: Serum Beta C-telopeptides (b-CTx), by Stratum

    Months 6, 12, 18 and 24

  • Biochemical Marker of Bone Formation: Serum N-terminal Propeptide of Type 1 Collagen (P1NP), by Stratum

    Months 6, 12, 18 and 24

  • Biochemical Marker of Bone Formation: Bone Serum Alkaline Phosphatase (BSAP), by Stratum

    Months 6, 12, 18 and 24

Study Arms (3)

Zoledronic Acid 2x5 mg

EXPERIMENTAL

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

Drug: Zoledronic Acid

Zoledronic Acid 1x5 mg

EXPERIMENTAL

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

Drug: Zoledronic AcidDrug: Placebo

Placebo

PLACEBO COMPARATOR

Placebo given at randomization and Month 12

Drug: Placebo

Interventions

Zoledronic AcidDRUG

Zoledronic acid 5 mg intravenous

Zoledronic Acid 1x5 mgZoledronic Acid 2x5 mg
PlaceboDRUG

Physiologic 0.9% normal saline

PlaceboZoledronic Acid 1x5 mg

Eligibility Criteria

Age45 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

For information regarding facilities, please contact the Central Contact

East Hanover, New Jersey, 07936, United States

Location

Related Publications (2)

  • 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.

    PMID: 21037195DERIVED

  • 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.

    PMID: 20168099DERIVED

MeSH Terms

Conditions

Bone Diseases, MetabolicOsteoporosis, Postmenopausal

Interventions

Zoledronic Acid

Condition Hierarchy (Ancestors)

Bone DiseasesMusculoskeletal DiseasesMetabolic DiseasesNutritional and Metabolic DiseasesOsteoporosis

Intervention Hierarchy (Ancestors)

DiphosphonatesOrganophosphonatesOrganophosphorus CompoundsOrganic ChemicalsImidazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Results Point of Contact

Title
Study Director
Organization
Novartis Pharmaceuticals
862-778-8300

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 18, 2005

First Posted

August 22, 2005

Study Start

July 1, 2004

Primary Completion

February 1, 2008

Study Completion

February 1, 2008

Last Updated

September 12, 2016

Results First Posted

January 10, 2011

Record last verified: 2016-08

Locations

US(1)