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

NCT00718861 | Completed Phase 3 Results DMC

• 2 other identifiers: CZOL446H2301E22007-005383-27
• Study Type: interventional
• Target: 190
• Locations: 18 countries
• Sites: 57

Brief Summary

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

Conditions

Post-menopausal Osteoporosis

Keywords

Osteoporosis; zoledronic acid; post-menopausal

Outcome Measures

Primary Outcomes (1)

• Percentage Change in Total Hip Bone Mineral Density BMD at Year 6 (Baseline) and Year 9

  Bone Mineral Density (BMD) measured by dual energy x-ray absorptiometry (DXA). DXA consists of two X-ray beams with different energy levels that are aimed at the patient's bones. When soft tissue absorption is subtracted out, the BMD can be determined from the absorption of each beam by bone. Percentage change from Year 6 = 100\*(Year 9 - Year 6)/Year 6.

  Year 6 (baseline) and Year 9

Secondary Outcomes (10)

• Percentage Change of Total Hip Bone Mineral Density (BMD) at Year 7 and 8 Compared to Year 6

  Year 6 (extension 2 baseline), Year 7, Year 8

• Percentage Change of Femoral Neck Bone Mineral Density (BMD) at Year 7, 8 and 9 Compared to Year 6

  Year 6 (extension 2 baseline), Year 7, Year 8, Year 9

• Percentage Change of Total Hip Bone Mineral Density (BMD) at Year 7, 8 and 9 Compared to Year 0

  Year 0 (core baseline), Year 7, Year 8, Year 9

• Percentage Change of Femoral Neck Bone Mineral Density (BMD) at Year 7, 8 and 9 Compared to Year 0

  Year 0 (core baseline), Year 7, Year 8, Year 9

• Biomarkers (Bone Markers) Serum C-terminal Telopeptide of Type I Collagen (CTx) at Year 6 (Extension 2 Baseline), Year 7, Year 8, Year 9

  Year 6 (extension 2 baseline), Year 7, Year 8, Year 9

Study Arms (2)

Placebo

PLACEBO COMPARATOR

Matching placebo administered intravenously.

Drug: Placebo

Zoledronic acid

EXPERIMENTAL

Drug: Zoledronic acid

Interventions

Placebo DRUG

Placebo

Zoledronic acid DRUG

Also known as: Reclast®, Aclasta®

Zoledronic acid

Eligibility Criteria

• Age: 65 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Novartis Pharmaceuticals: lead

Study Sites (57)

Novartis Investigative Site

San Diego, California, 92103-6204, United States

Location

Novartis Investigative Site

Lakewood, Colorado, 80227, United States

Location

Novartis Investigative Site

Gainesville, Georgia, 30501, United States

Location

Novartis Investigative Site

Indiamapolis, Indiana, 46202, United States

Location

Novartis Investigative Site

Bangor, Maine, 04401, United States

Location

Novartis Investigative Site

Albuquerque, New Mexico, 87106, United States

Location

Novartis Investigative Site

Fargo, North Dakota, 58103, United States

Location

Novartis Investigative Site

Pittsburgh, Pennsylvania, 15261, United States

Location

Novartis Investigative Site

Richmond, Virginia, 23249, United States

Location

Novartis Investigative Site

Seattle, Washington, 98144, United States

Location

Novartis Investigative Site

Buenos Aires, Buenos Aires, C1117ABH, Argentina

Location

Novartis Investigative Site

Caba, Buenos Aires, C1221ADC, Argentina

Location

Novartis Investigative Site

Quilmes, Buenos Aires, B1878DVB, Argentina

Location

Novartis Investigative Site

St Leonards, New South Wales, 2065, Australia

Location

Novartis Investigative Site

Geelong, Victoria, 3220, Australia

Location

Novartis Investigative Site

Parkville, Victoria, 3052, Australia

Location

Novartis Investigative Site

Ghent, 9000, Belgium

Location

Novartis Investigative Site

Leuven, 3000, Belgium

Location

Novartis Investigative Site

Vancouver, British Columbia, V5Z 2K4, Canada

Location

Novartis Investigative Site

Montreal, Quebec, H3A 1A1, Canada

Location

Novartis Investigative Site

Sainte-Foy, Quebec, G1v 3M7, Canada

Location

Novartis Investigative Site

Barranquilla, Colombia

Location

Novartis Investigative Site

Bogotá, Colombia

Location

Novartis Investigative Site

Medellín, Colombia

Location

Novartis Investigative Site

Helsinki, 00100, Finland

Location

Novartis Investigative Site

Lyon, France, 69003, France

Location

Novartis Investigative Site

Berlin, 12200, Germany

Location

Novartis Investigative Site

Braunfels, 35619, Germany

Location

Novartis Investigative Site

Hanover, 30167, Germany

Location

Novartis Investigative Site

Magdeburg, 39110, Germany

Location

Novartis Investigative Site

München, 80809, Germany

Location

Novartis Investigative Site

Hong Kong, Hong Kong

Location

Novartis Investigative Site

Balatonfüred, 8230, Hungary

Location

Novartis Investigative Site

Budapest, 1023, Hungary

Location

Novartis Investigative Site

Budapest, 1083, Hungary

Location

Novartis Investigative Site

Budapest, 1085, Hungary

Location

Novartis Investigative Site

Debrecen, 4012, Hungary

Location

Novartis Investigative Site

Győr, 9023, Hungary

Location

Novartis Investigative Site

Arenzano, GE, 16011, Italy

Location

Novartis Investigative Site

Padua, PD, 35128, Italy

Location

Novartis Investigative Site

Siena, SI, 53100, Italy

Location

Novartis Investigative Site

Valeggio sul Mincio, VR, 37067, Italy

Location

Novartis Investigative Site

Grafton, Auckland, New Zealand

Location

Novartis Investigative Site

Bergen, 5094, Norway

Location

Novartis Investigative Site

Hamar, 2317, Norway

Location

Novartis Investigative Site

Oslo, 0050, Norway

Location

Novartis Investigative Site

Oslo, 0176, Norway

Location

Novartis Investigative Site

Warsaw, Poland, 04-730, Poland

Location

Novartis Investigative Site

Bialystok, 15-337, Poland

Location

Novartis Investigative Site

Warsaw, 00-416, Poland

Location

Novartis Investigative Site

Warsaw, 02-341, Poland

Location

Novartis Investigative Site

Gothenburg, 413 45, Sweden

Location

Novartis Investigative Site

Stockholm, SE-171 76, Sweden

Location

Novartis Investigative Site

Bern, 3010, Switzerland

Location

Novartis Investigative Site

Zurich, 8091, Switzerland

Location

Novartis Investigative Site

Chaingmai, 50200, Thailand

Location

Novartis Investigative Site

Khonkaen, 40002, Thailand

Location

MeSH Terms

Conditions

Osteoporosis, Postmenopausal; Osteoporosis

Interventions

Zoledronic Acid

Condition Hierarchy (Ancestors)

Bone Diseases, Metabolic; Bone Diseases; Musculoskeletal Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Diphosphonates; Organophosphonates; Organophosphorus Compounds; Organic Chemicals; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Study Director
• Organization: Novartis Pharmaceuticals

8627788300

Study Officials

• Novartis Pharmaceuticals

  Novartis Pharmaceuticals

  STUDY DIRECTOR

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: July 18, 2008
• First Posted: July 21, 2008
• Study Start: May 1, 2008
• Primary Completion: April 1, 2013
• Study Completion: April 1, 2013
• Last Updated: October 9, 2014
• Results First Posted: December 30, 2013

Record last verified: 2014-09

Locations

AR (3); TH (2); AU (3); PL (4); CH (2); DE (5); HK (1); US (10); CO (3); FR (1); NZ (1); HU (6); CA (3); BE (2); FI (1); NO (4); IT (4); SE (2)