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3 yr Efficacy & Safety Study of Zoledronic Acid in Post-menopausal Women With Osteoporosis Treated With Zol Acid for 6 Yrs

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT00718861
First received: July 18, 2008
Last updated: May 13, 2013
Last verified: May 2013
History of Changes
  Purpose

This second extension will evaluate the efficacy and long term safety of zoledronic acid in women with post-menopausal osteoporosis


Condition Intervention Phase
Post-menopausal Osteoporosis
 Drug: Placebo
Drug: Zoledronic acid
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A 3-year, Multicenter, Double-blind, Randomized, Placebo-controlled Extension to CZOL446H2301E1 to Evaluate the Efficacy and Long Term Safety of 6 and 9 Years Zoledronic Acid Treatment of Postmenopausal Women With Osteoporosis

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Novartis:

Primary Outcome Measures:
  • The percentage change in total hip BMD at Year 6 (baseline) and Year 9 [ Time Frame: Year 6 (baseline) and Year 9 ] [ Designated as safety issue: No ]
    BMD measured by DXA (dual energy x-ray absorptiometry).


Secondary Outcome Measures:
  • Differences between treatment groups in the percentage change of total hip and femoral neck BMD (bone mineral density) at year 7, 8 and 9 compared to year 0 [ Time Frame: Year 0 (baseline), Year 7, Year 8, Year 9 ] [ Designated as safety issue: No ]
    BMD measured by DXA (dual energy x-ray absorptiometry).

  • Differences between treatment groups in the percentage change of total hip BMD at year 7 and 8 compared to year 6 [ Time Frame: Year 6 (baseline), Year 7, Year 8 ] [ Designated as safety issue: No ]
    BMD measured by DXA (dual energy x-ray absorptiometry).

  • Relative change in biomarkers [ Time Frame: Year 6 (baseline), Year 7, Year 8, Year 9 ] [ Designated as safety issue: No ]
    Serum samples analyzed for parameters of renal and endocrine function including PTH, TSH, Vitamin D and markers of bone turnover.

  • Relative change in height [ Time Frame: Year 6 (baseline), Year 9 ] [ Designated as safety issue: No ]
    Height will be measured using a stadiometer.

  • Differences between treatment groups in the number of clinical fractures [ Time Frame: Year 6 (baseline), Year 7, Year 8, Year 9 ] [ Designated as safety issue: No ]
    An x-ray of a current vertebral fracture will be obtained and compared to baseline study radiograph and be defined by semi-quantitative reading. Other clinical fractrures may be confirmed with x-rays, radiology reports or surgical documentation.


Enrollment: 137
Study Start Date: May 2008
Study Completion Date: April 2013
Primary Completion Date: April 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo
Matching placebo administered intravenously.
 Drug: Placebo
Experimental: Zoledronic acid Drug: Zoledronic acid
Other Name: Reclast®, Aclasta®

  Eligibility

Ages Eligible for Study:   65 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Women who have received the 4th and 6th dose of zoledronic acid in study CZOL446H2301E1

Exclusion Criteria:

  • Poor kidney, eye, liver health
  • Use of certain therapies for osteoporosis in study CZOL446H2301E1
  • Abnormal calcium levels

Other protocol-defined inclusion/exclusion criteria may apply

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00718861

  Show 66 Study Locations
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
  More Information

No publications provided

Responsible Party: Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier: NCT00718861     History of Changes
Other Study ID Numbers: CZOL446H2301E2, 2007-005383-27
Study First Received: July 18, 2008
Last Updated: May 13, 2013
Health Authority: United States: Food and Drug Administration
European Union: European Medicines Agency
Australia: Department of Health and Ageing Therapeutic Goods Administration
Argentina: Ministry of Health
Canada: Canadian Institutes of Health Research
Colombia: INVIMA Instituto Nacional de Vigilancia de Medicamentos y Alimentos
New Zealand: Medsafe
Norway: Norwegian Medicines Agency
Russia: Ministry of Health of the Russian Federation
Switzerland: Swissmedic
Thailand: Ministry of Public Health

Keywords provided by Novartis:
Osteoporosis
zoledronic acid
post-menopausal

Additional relevant MeSH terms:
Osteoporosis
Osteoporosis, Postmenopausal
Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases
 Zoledronic acid
Diphosphonates
Bone Density Conservation Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 16, 2013