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Completed

NCT Number: NCT00145327

Double-blind Extension of HORIZON Pivotal Fracture Trial (Zoledronic Acid in the Treatment of Postmenopausal Osteoporosis)

This extension study is designed to assess the long term safety and efficacy of zoledronic acid in postmenopausal women with osteoporosis who have participated in the CZOL446H2301 (NCT00049829): HORIZON Pivotal Fracture Trial. This extension study began after the 3-year core study ended. Baseline is the same as Year 3.

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Key information

Conditions

Osteoporosis Bone Diseases Bone Diseases, Metabolic Metabolic Diseases Musculoskeletal Diseases Nutritional and Metabolic Diseases

Age range

68 year–90 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

Primary location

Novartis, Nuremberg, Germany

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients who have received 3 infusions in the HORIZON-Pivotal Fracture (PFT) Study.

Exclusion criteria

  • Poor kidney, eye, or liver health
  • Use of certain therapies for osteoporosis in the HORIZON-PFT study (other than the study medication)
  • Abnormal calcium levels in the blood

Other protocol-defined inclusion/exclusion criteria may apply.

Treatment and study plan

Zoledronic acid

Drug

Zoledronic Acid 5 mg in 100 mL physiologic 0.9% normal saline for intravenous infusion.

Other names: Reclast, Aclasta

Placebo

Drug

100 mL physiologic 0.9% normal saline for intravenous infusion.

Other names: Reclast, Aclasta

Primary outcomes

  1. Percentage Change in Bone Mineral Density (BMD) of Femoral Neck at Year 6 Relative to Year 3

    Time frame: Year 3 (Extension Baseline; Month 36 prior to the first treatment of the extension study) and Year 6 (Month 72; end of extension study)

    The primary efficacy variable was the percentage change in BMD of the femoral neck as measured by dual x-ray absorptiometry (DXA) at Year 6 relative to Year 3. It was derived as 100 *(femoral neck BMD at Year 6 - femoral neck BMD at Year 3) / (femoral neck BMD at Year 3).

Secondary outcomes

  1. Bone Resorption and Formation Biochemical Markers at Year 4.5: P1NP

    Time frame: Year 4.5

    The amount of serum n-terminal propeptide of type I collagen (P1NP) as determined by the central laboratory.

  2. Bone Resorption and Formation Biochemical Markers at Year 6: P1NP

    Time frame: Year 6

    The amount of serum P1NP as determined by the central laboratory

  3. Percentage Change in BMD of Lumbar Spine at Year 4.5 Relative to Year 3

    Time frame: Year 3 (Extension Baseline; Month 36 prior to the first treatment of the extension study) and Year 4.5 (Month 54)

    The percentage change in BMD as measured by DXA at Year 4.5 relative to Year 3. It was derived as 100 * (BMD at Year 4.5 - BMD at Year 3)/(BMD at Year 3).

  4. Percentage Change in BMD of Lumbar Spine at Year 6 Relative to Year 3

    Time frame: Year 3 (Extension Baseline; Month 36 prior to the first treatment of the extension study) and Year 6

    The percentage change in BMD as measured by DXA at Year 6 relative to Year 3. It was derived as 100 * (BMD at Year 6 - BMD at Year 3)/(BMD at Year 3).

  5. Percentage Change in BMD of Distal Radius at Year 4.5 Relative to Year 3

    Time frame: Year 3 (Extension Baseline; Month 36 prior to the first treatment of the extension study) and Year 4.5 (Month 54)

    The percentage change in BMD as measured by DXA at Year 4.5 relative to Year 3. It was derived as 100 * (BMD at Year 4.5 - BMD at Year 3)/(BMD at Year 3).

  6. Percentage Change in BMD of Distal Radius at Year 6 Relative to Year 3

    Time frame: Year 3 (Extension Baseline; Month 36 prior to the first treatment of the extension study) and Year 6 (Month 72)

    The percentage change in BMD as measured by DXA at Year 6 relative to Year 3. It was derived as 100 * (BMD at Year 6 - BMD at Year 3)/(BMD at Year 3).

  7. Percentage Change in BMD of Femoral Neck, Total Hip and Trochanter at Year 4.5 Relative to Year 3

    Time frame: Year 3 (Extension Baseline; Month 36 prior to the first treatment of the extension study) and Year 4.5 (Month 54)

    The percentage change in BMD as measured by DXA at 4.5 relative to Year 3. It was derived as 100 * (BMD at Year 4.5 - BMD at Year 3)/(BMD at Year 3).

  8. Percentage Change in BMD of Femoral Neck, Total Hip and Trochanter at Year 6 Relative to Year 3

    Time frame: Year 3 (Extension Baseline; Month 36 prior to the first treatment of the extension study) and Year 6 (Month 72)

    The percentage change in BMD as measured by DXA at Year 6 relative to Year 3. It was derived as 100 * (BMD at Year 6 - BMD at Year 3)/(BMD at Year 3).

  9. Percentage of Patients With New and New/Worsening Morphometric Vertebral Fractures

    Time frame: Year 3 (Extension Baseline; Month 36 prior to the first treatment of the extension study) and Year 6

    Lateral vertebral x-rays were performed at the final core study visit and at Year 6 and read by a central expert reader at a central imaging laboratory to assess for new or new/worsening morphometric vertebral fracture. The percentage of patients with new morphometric vertebral fractures (observed for the first time) and patients with either new or worsening morphometric vertebral fractures was calculated.

  10. Number of Participants With Incidence of Clinical Fracture

    Time frame: Extension Baseline (Year 3; Month 36) to Year 6

    Clinical fracture excludes finger, toe, and facial bone fractures. Clinical vertebral fracture includes thoracic spine fracture and lumbar spine fracture. Non-vertebral fracture excludes clinical vertebral, finger, toe, and facial bone fractures.

  11. Qualitative Bone Biopsy Parameters

    Time frame: End of Study Visit at Year 6

    Unpaired transiliac crest bone biopsy was performed for histomorphometry, which was obtained after double tetracycline labeling. No data were collected for Patients who received Placebo for the first 3 years of the study (Placebo 3 Zoledronic Acid 3).

  12. Change in Serum Creatinine From Baseline to 9-11 Days Post Year 3 Infusion

    Time frame: Extension Baseline (Year 3; Month 36 prior to the first treatment of the extension study) to 9-11 days after the Year 3 infusion

    Serum creatinine measurements performed by a central laboratory was used to evaluate acute changes in renal function 9-11 days after study drug infusion in Z6 patients compared to Z3P3 patients and in P3Z3 patients.

  13. Change in Serum Creatinine From Baseline to 9-11 Days Post Year 4 Infusion

    Time frame: Extension Baseline (Year 3; Month 36 prior to the first treatment of the extension study) to 9-11 days after the Year 4 infusion

    Serum creatinine measurements performed by a central laboratory was used to evaluate acute changes in renal function 9-11 days after Year 4 study drug infusion.

  14. Change in Serum Creatinine From Baseline to 9-11 Days Post Year 5 Infusion

    Time frame: Extension Baseline (Year 3; Month 36 prior to the first treatment of the extension study) to 9-11 days after the Year 5 infusion

    Serum creatinine measurements performed by a central laboratory was used to evaluate acute changes in renal function 9-11 days after Year 5 study drug infusion.

  15. The Number of Participants With Clinically Significant Laboratory Parameters

    Time frame: Extension Baseline (Year 3; Month 36 prior to the first treatment of the extension study) to Year 6

    Evaluate the laboratory key profile such as Calcium, Creatinine and Urea. The number of patients with clinically significant calcium, creatinine and urea were reported.

Sponsors and collaborators

Lead sponsor

Novartis

Industry

Registry information

Official study title

A 3-year, Double-blind Extension to CZOL446H2301 to Evaluate the Long-term Safety and Efficacy of Zoledronic Acid in the Treatment of Osteoporosis in Postmenopausal Women Taking Calcium and Vitamin D

Important dates

Study start
2005
Primary completion
2009
Study completion
2009
First posted
Sep 5, 2005
Registry last updated
Jun 28, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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