Safety/Efficacy of Zoledronic Acid and Alendronate on Bone Metabolism in Postmenopausal Women With Osteoporosis

NCT00404820 | Completed Phase 3 Results

• 1 other identifier: CZOL446HDE31
• Study Type: interventional
• Target: 604
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this study was to examine the effect of zoledronic acid and alendronate on bone metabolism as measured by biomarkers in postmenopausal women with osteoporosis.

Conditions

Osteoporosis

Keywords

osteoporosis; bisphosphonate; biomarker; zoledronic acid; alendronate; postmenopausal

Outcome Measures

Primary Outcomes (2)

• Change of Cross-linked N-telopeptide of Type I Collagen (NTx) Level Assessed as Standardized Area Under the Curve From Screening to Month 12 in the Intent-to-Treat Population

  The level of bone activity as measured by NTx over the course of 12 months was assessed using the standardized area under the curve. Blood samples were collected after an overnight fast of at least 8 hours between 7:00 and 11:00 AM at Screening and Months 1.5, 3, 6, 9, and 12 months after baseline. Serum was analyzed at a central lab using commercially available ELISA kits. Standardized AUC was calculated by the AUC divided by the number of days the patient participated in the study.

  Screening to end of study (Month 12)

• Change of Cross-linked N-telopeptide of Type I Collagen (NTx) Level Assessed as Standardized Area Under the Curve From Screening to Month 12 in the Per Protocol Population

  The level of bone activity as measured by NTx over the course of 12 months was assessed using the standardized area under the curve. Blood samples were collected after an overnight fast of at least 8 hours between 7:00 and 11:00 AM at Screening and Months 1.5, 3, 6, 9, and 12 months after baseline. Serum was analyzed at a central lab using commercially available ELISA kits. Standardized AUC was calculated by the AUC divided by the number of days the patient participated in the study.

  Screening to end of study (Month 12)

Secondary Outcomes (5)

• Change of Procollagen Type I Nitrogenous Propeptide (P1NP) Level Assessed as Standardized Area Under the Curve From Screening to Month 12

  Screening to end of study (Month 12)

• Change in the Qualeffo-41 Quality of Life (QoL) Questionnaire Score From Baseline to Month 12

  Baseline to end of study (Month 12)

• Number of Patients With a Clinical Fracture From Baseline to Month 12

  Baseline to end of study (Month 12)

• Change in Body Height From Baseline to Month 12

  Baseline to end of study (Month 12)

• Therapy Preference at End of Study (Month 12)

  Month 12

Study Arms (2)

Zoledronic acid 5 mg

EXPERIMENTAL

Patients received zoledronic acid 5 mg in 100 ml solution in a 15 minute intravenous (iv) infusion once per year. The peripheral iv infusion was preceded by and followed by a 10 ml normal saline flush of the intravenous line. In addition to study therapy, all participants received 1200 mg elemental calcium and 800 IU of vitamin D daily. Calcium and vitamin D were supplied in a chewable tablet that was to be taken twice daily.

Drug: Zoledronic acid 5 mg solution; Drug: Calcium/Vitamin D

Alendronate 70 mg

ACTIVE COMPARATOR

Patients received an alendronate 70 mg tablet once weekly with 200 ml of tap water in the morning on an empty stomach at least 30 minutes before the first meal. Patients were to remain in an upright position for 30 minutes after swallowing the tablet. In addition to study therapy, all participants received 1200 mg elemental calcium and 800 IU of vitamin D daily. Calcium and vitamin D were supplied in a chewable tablet that was to be taken twice daily.

Drug: Alendronate 70 mg tablets; Drug: Calcium/Vitamin D

Interventions

Zoledronic acid 5 mg solution DRUG

Zoledronic acid was supplied as a concentrate of 5.33 mg zoledronic acid monohydrate in a 100 ml solution. 5.33 mg zoledronic acid monohydrate equals 5 mg zoledronic acid.

Zoledronic acid 5 mg

Alendronate 70 mg tablets DRUG

Patients received an alendronate 70 mg tablet once weekly with 200 ml of tap water in the morning on an empty stomach at least 30 minutes before the first meal.

Alendronate 70 mg

Calcium/Vitamin D DRUG

Combined elemental calcium / vitamin D chewable tablets. Participants took 2 tablets a day, for a daily dose of calcium 1200 mg/vitamin D 800 IU.

Alendronate 70 mg; Zoledronic acid 5 mg

Eligibility Criteria

• Age: 55 Years - 90 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \- Low bone mineral density (as indicated by a "t-score" of -2.0 or lower) postmenopausal women

You may not qualify if:

• \- Previous use of oral and iv bisphosphonates, parathormone, strontium ranelate, sodium fluoride.

Sponsors & Collaborators

• Novartis: lead

Study Sites (1)

For site information contact Novartis Pharmaceuticals

Multiple Cities, Germany

Location

MeSH Terms

Conditions

Osteoporosis

Interventions

Zoledronic Acid; Solutions; Alendronate; Calcium; Vitamin D

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; Pharmaceutical Preparations; Metals, Alkaline Earth; Elements; Inorganic Chemicals; Metals; Blood Coagulation Factors; Biological Factors; Secosteroids; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Results Point of Contact

• Title: Study Director
• Organization: Novartis Pharmaceuticals

862 778-8300

Study Officials

• Novartis Pharma GmbH, Germany +49 911 273-0

  Novartis

  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: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: November 28, 2006
• First Posted: November 29, 2006
• Study Start: October 1, 2006
• Primary Completion: December 1, 2008
• Study Completion: December 1, 2008
• Last Updated: July 1, 2011
• Results First Posted: July 1, 2011

Record last verified: 2011-06

Locations

DE (1)