Back to resultsSafety/Efficacy of Zoledronic Acid and Alendronate on Bone Metabolism in Postmenopausal Women With Osteoporosis (ROSE)
Primary Purpose
Osteoporosis
Status
Completed
Phase
Phase 3
Locations
Germany
Study Type
Interventional
Intervention
Zoledronic acid 5 mg solution
Alendronate 70 mg tablets
Calcium/Vitamin D
Sponsored by
About this trial
This is an interventional treatment trial for Osteoporosis focused on measuring osteoporosis, bisphosphonate, biomarker, zoledronic acid, alendronate, postmenopausal
Eligibility Criteria
Inclusion Criteria:
- Low bone mineral density (as indicated by a "t-score" of -2.0 or lower) postmenopausal women
Exclusion Criteria:
- Previous use of oral and iv bisphosphonates, parathormone, strontium ranelate, sodium fluoride.
Other protocol-defined inclusion/exclusion criteria applied to the study.
Sites / Locations
- For site information contact Novartis Pharmaceuticals
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Zoledronic acid 5 mg
Alendronate 70 mg
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
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.
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.
Secondary Outcome Measures
Change of Procollagen Type I Nitrogenous Propeptide (P1NP) Level Assessed as Standardized Area Under the Curve From Screening to Month 12
The level of bone activity as measured by P1NP 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.
Change in the Qualeffo-41 Quality of Life (QoL) Questionnaire Score From Baseline to Month 12
The Qualeffo-41 QoL questionnaire was completed by the patient at Baseline and at Month 12. The questionnaire includes 41 questions covering 7 domains (pain, physical function and activities of daily living, physical function and jobs around the house, physical function and mobility, leisure and social activities, general health perception, mental function). Scores on each question range from 1 to 3, 4, or 5. The total score summed over all questions ranges from 41-205 points; the lower the score the higher the quality of life. A negative change score indicates improvement.
Number of Patients With a Clinical Fracture From Baseline to Month 12
A diagnosis of clinical fracture was based on physical examination findings, ie, swelling, tenderness, limited movement, pain.
Change in Body Height From Baseline to Month 12
Body height was measured at Baseline and at the end of the study (Month 12) and the change in height calculated.
Therapy Preference at End of Study (Month 12)
Patients were administered a questionnaire at the end of the study in which they were asked which type of therapy, weekly oral or yearly iv, they preferred.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00404820
Brief Title
Safety/Efficacy of Zoledronic Acid and Alendronate on Bone Metabolism in Postmenopausal Women With Osteoporosis
Acronym
ROSE
Official Title
A Multi-center, Randomized, Open-label, Controlled, One-year Trial to Measure the Effect of Zoledronic Acid and Alendronate on Bone Metabolism in Postmenopausal Women With Osteopenia and Osteoporosis
Study Type
Interventional
2. Study Status
Record Verification Date
June 2011
Overall Recruitment Status
Completed
Study Start Date
October 2006 (undefined)
Primary Completion Date
December 2008 (Actual)
Study Completion Date
December 2008 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Novartis
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoporosis
Keywords
osteoporosis, bisphosphonate, biomarker, zoledronic acid, alendronate, postmenopausal
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
604 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Zoledronic acid 5 mg
Arm Type
Experimental
Arm Description
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.
Arm Title
Alendronate 70 mg
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Zoledronic acid 5 mg solution
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Alendronate 70 mg tablets
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Calcium/Vitamin D
Intervention Description
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.
Primary Outcome Measure Information:
Title
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
Description
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.
Time Frame
Screening to end of study (Month 12)
Title
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
Description
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.
Time Frame
Screening to end of study (Month 12)
Secondary Outcome Measure Information:
Title
Change of Procollagen Type I Nitrogenous Propeptide (P1NP) Level Assessed as Standardized Area Under the Curve From Screening to Month 12
Description
The level of bone activity as measured by P1NP 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.
Time Frame
Screening to end of study (Month 12)
Title
Change in the Qualeffo-41 Quality of Life (QoL) Questionnaire Score From Baseline to Month 12
Description
The Qualeffo-41 QoL questionnaire was completed by the patient at Baseline and at Month 12. The questionnaire includes 41 questions covering 7 domains (pain, physical function and activities of daily living, physical function and jobs around the house, physical function and mobility, leisure and social activities, general health perception, mental function). Scores on each question range from 1 to 3, 4, or 5. The total score summed over all questions ranges from 41-205 points; the lower the score the higher the quality of life. A negative change score indicates improvement.
Time Frame
Baseline to end of study (Month 12)
Title
Number of Patients With a Clinical Fracture From Baseline to Month 12
Description
A diagnosis of clinical fracture was based on physical examination findings, ie, swelling, tenderness, limited movement, pain.
Time Frame
Baseline to end of study (Month 12)
Title
Change in Body Height From Baseline to Month 12
Description
Body height was measured at Baseline and at the end of the study (Month 12) and the change in height calculated.
Time Frame
Baseline to end of study (Month 12)
Title
Therapy Preference at End of Study (Month 12)
Description
Patients were administered a questionnaire at the end of the study in which they were asked which type of therapy, weekly oral or yearly iv, they preferred.
Time Frame
Month 12
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
55 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
- Low bone mineral density (as indicated by a "t-score" of -2.0 or lower) postmenopausal women
Exclusion Criteria:
- Previous use of oral and iv bisphosphonates, parathormone, strontium ranelate, sodium fluoride.
Other protocol-defined inclusion/exclusion criteria applied to the study.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Novartis Pharma GmbH, Germany +49 911 273-0
Organizational Affiliation
Novartis
Official's Role
Study Director
Facility Information:
Facility Name
For site information contact Novartis Pharmaceuticals
City
Multiple Cities
Country
Germany
12. IPD Sharing Statement
Learn more about this trial
Safety/Efficacy of Zoledronic Acid and Alendronate on Bone Metabolism in Postmenopausal Women With Osteoporosis
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