OsteopeniaPhase 3NCT00132808
Zoledronic Acid in the Prevention of Bone Loss in Postmenopausal Women With Osteopenia, 45 Years of Age and Older
A Phase 3 study testing Zoledronic Acid in people with Osteopenia, run by Novartis Pharmaceuticals at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 45 years and older, women only
- Conditions the study is for
- Osteopenia
- What is being tested?
- Zoledronic Acid
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 581 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2004to Feb 2008
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
For information regarding facilities, please contact the Central Contact
East Hanover, New Jersey, 07936
About this study
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
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.
- Conditions
- Osteopenia
- Being tested
- Zoledronic Acid, Placebo
- Keywords
- Postmenopausal osteoporosis, osteopenia, zoledronic acid, Osteopenia (osteoporosis prevention)
- Medical subject headings
- Bone Diseases, Metabolic, Osteoporosis, Postmenopausal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Zoledronic AcidDrug
Zoledronic acid 5 mg intravenous
PlaceboDrug
Physiologic 0.9% normal saline
| Study group | Role | What they receive |
|---|---|---|
| Zoledronic Acid 2x5 mg | Experimental | Zoledronic acid 5 mg intravenous (i.v.) given at randomization and Month 12 Receives: Drug: Zoledronic Acid |
| Zoledronic Acid 1x5 mg | Experimental | Zoledronic acid 5 mg intravenous (i.v.) given at randomization and placebo at Month 12 Receives: Drug: Zoledronic Acid; Drug: Placebo |
| Placebo | Placebo comparator | Placebo given at randomization and Month 12 Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Baseline, Month 24
Secondary outcomes (5)
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).
Measured: Baseline, Month 24
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).
Measured: Baseline, Month 24
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.
Measured: Months 6, 12, 18 and 24
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.
Measured: Months 6, 12, 18 and 24
Biochemical Marker of Bone Formation: Bone Serum Alkaline Phosphatase (BSAP), by Stratum
Biomarker: BSAP levels at Months 6, 12, 18 and 24 by stratum.
Measured: Months 6, 12, 18 and 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2005 (estimated)
- Study startJul 2004
- Primary completionFeb 2008
- Study completionFeb 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for OsteopeniaStudies of the same condition, open and under way.
- More trials run by Novartis PharmaceuticalsThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 581 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novartis Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00132808
- Sponsor's protocol ID
- CZOL446N2312
- Status last verified
- Aug 2016
- First submitted
- 18 Aug 2005
- Last updated
- 12 Sep 2016
- Results posted
- Yes, on ClinicalTrials.gov
Publications
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.
PubMed 21037195McClung 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.
PubMed 20168099
Study at a glance
From the registry record, last updated by the sponsor on 12 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00132808
- Acronym / sponsor ID
- CZOL446N2312
- Conditions
- Osteopenia
- Keywords
- Postmenopausal osteoporosis, osteopenia, zoledronic acid, Osteopenia (osteoporosis prevention)
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 581 participants (actual)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Jul 2004
- Primary completion
- Feb 2008 (actual)
- Study completion
- Feb 2008 (actual)
- First posted
- 22 Aug 2005 (estimated)
- Results
- Posted 10 Jan 2011
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Zoledronic Acid 2x5 mg | Experimental | Drug: Zoledronic AcidZoledronic acid 5 mg intravenous (i.v.) given at randomization and Month 12 |
| Zoledronic Acid 1x5 mg | Experimental | Drug: Zoledronic Acid, Drug: PlaceboZoledronic acid 5 mg intravenous (i.v.) given at randomization and placebo at Month 12 |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo given at randomization and Month 12 |
Who may qualify
- Ages
- 45 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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)
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Zoledronic AcidZoledronic acid 5 mg intravenous | Drug | Zoledronic Acid 1x5 mg, Zoledronic Acid 2x5 mg |
| PlaceboPhysiologic 0.9% normal saline | Drug | Placebo, Zoledronic Acid 1x5 mg |
Primary outcome
Percentage Change in Lumbar Spine Bone Mineral Density (BMD) at Month 24 Relative to Baseline, by Stratum
Time frame: Baseline, Month 24
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).
5 secondary outcomes
Percentage Change in Total Hip BMD at Month 24 Relative to Baseline, by Stratum.
Time frame: Baseline, Month 24
Percentage Change in Femoral Neck BMD at Month 24 Relative to Baseline, by Stratum.
Time frame: Baseline, Month 24
Biochemical Marker of Bone Resorption: Serum Beta C-telopeptides (b-CTx), by Stratum
Time frame: Months 6, 12, 18 and 24
Biochemical Marker of Bone Formation: Serum N-terminal Propeptide of Type 1 Collagen (P1NP), by Stratum
Time frame: Months 6, 12, 18 and 24
Biochemical Marker of Bone Formation: Bone Serum Alkaline Phosphatase (BSAP), by Stratum
Time frame: Months 6, 12, 18 and 24
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Sep 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 21037195Grbic 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.
- Derived from this study: PubMed 20168099McClung 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Zoledronic Acid in people with Osteopenia, run by Novartis Pharmaceuticals at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Sep 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 10 Jan 2011). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage Change in Lumbar Spine Bone Mineral Density (BMD) at Month 24 Relative to Baseline, by Stratum (time frame: Baseline, Month 24). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00132808, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Sep 2016.