- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00259857
Safety and Efficacy of Alendronate (Fosamax) in Children With Osteoporosis
December 29, 2010 updated by: Medical University of South Carolina
A Randomized, Double-Blind, Placebo-Controlled, Prospective, Cross-Over Phase II Clinical Trial to Determine the Safety and Efficacy of Alendronate (Fosamax) in Juvenile Osteoporosis (IND#60,017)
We have previously evaluated the safety and efficacy of Alendronate in 10 patients with juvenile osteoporosis during a 12-month clinical trial.
We have documented that Alendronate improved BMD of the spine and hip without any major side effects.
There were no additional fractures during therapy.
The present study is designed to further evaluate the safety and efficacy of Alendronate in 20 children with juvenile osteoporosis using a double-blind, randomized, placebo-controlled, cross-over protocol.
Study Overview
Detailed Description
Osteoporosis is an uncommon disease in children and early adolescents.
Patients have a low bone mineral density, develop fractures with minimal or no trauma, and frequently have a negative family history.
The disease results from either diminished bone formation or increased bone removal (resorption).
No specific drug therapy has been recommended for juvenile osteoporosis.
Alendronate (Fosamax) is effective in inhibiting bone resorption, increasing BMD and reducing fractures in adults with postmenopausal osteoporosis, but have not become established therapies in children.
In the present study, we plan to evaluate the safety and efficacy of Alendronate in 20 patients with juvenile osteoporosis in a two-year period.
This is a randomized, double-blind, placebo-controlled protocol.
In the year-1, 10 patients will be assigned to receive Alendronate and 10 patients placebo.
In the year-2, patients will be crossed over to the second arm of the study.
Those who received Alendronate in the year-1, will receive placebo in the second year and vice verse.
The patients will have 5 visits, the initial screening visit followed by 4 post therapy visits in a six-month interval.
Measurements include DXA bone density scan of spine and hip, urinalysis and blood work.
Study Type
Interventional
Enrollment (Actual)
22
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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South Carolina
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Charleston, South Carolina, United States, 29425
- Medical University of South Carolina
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
3 years to 13 years (Child)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Eligibility Criteria:
- 5-15 yrs of age
- Weighing 20 kg and more
- History of multiple fractures
- Tanner stage II or less
- Osteoporosis by DXA.
Inclusion Criteria:
- Male and female children with a history of one or more atraumatic fractures, or evidence of one or more compression fractures on radiographs of the spine (reduction of >20 percent).
- Bone Mineral Density (BMD) determined by DXA sacn to confirm osteoporosis at a Z score greater than 2 SD (standard deviations) below the normal mean for age (Z score < -2 SD).
- Parental consent (and patient assent after age 12 years) to participate in the study.
- Sexual development at: Tanner stage II or less (Prepubertal stage).
- Weight = 20 kg and more.
Exclusion Criteria:
- History of severe gastritis or reflux.
- Abnormalities of the esophagus that delay emptying, such as strictures or achalasia
- Marked kyphoscoliosis or the inability to sit or stand for at least 30 minutes
- Hypersensitivity to bisphosphonates
- Uncorrected hypocalcemia
- History of gastric or duodenal ulcers
- Renal dysfunction as indicated by serum Cr >1.5 mg/dl.
- Liver dysfunction as indicated by serum SGPT > 2 times the upper limit for age or serum total bilirubin > 2.0 mg/dl.
- Diagnosis of osteogenesis imperfecta, a family history of osteogenesis imperfecta, blue sclerae or deafness.
- Diagnosis of active rickets or osteomalacia or serum bone alkaline phosphatase 2 times greater than normal for age.
- Pregnancy
- Anorexia Nervosa
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: 1 Alendronate, Calcium, Vitamin D
Crossover study.
Year-1, 10 participants will take study medication, calcium and vitamin D supplements and other 10 participants will take placebo, calcium and vitamin D supplements.
Year-2, they will crossover to the second arm of the study.
Those who took study medication and supplements in year-1, will take placebo and supplements in the year-2, and those 10 participants who took placebo and supplements in the year-1, will take study medications and supplements in the year-2.
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Group-1/Year-1:Alendronate, pill, 35mg or 70mg, weekly; calcium, pill, 500mg or 1000mg daily; vitamin D, liquid, 800IU, daily, depending upon the body weight, for 12 months.
Group-1/Year-2:Placebo, pill, 35mg or 70mg, weekly; calcium, pill, 500mg or 1000mg daily; vitamin D, liquid, 800IU, daily, depending upon the body weight for 12 months.
Group-2/Year-1:Placebo, pill, 35mg or 70mg, weekly; calcium, pill, 500mg or 1000mg daily; vitamin D, liquid, 800IU, daily, depending upon the body weight for 12 months.
Group-2/Year-2: Alendronate, pill, 35mg or 70mg, weekly; calcium, pill, 500mg or 1000mg daily; vitamin D, liquid, 800IU, daily, depending upon the body weight for 12 months.
Other Names:
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Placebo Comparator: 2 Placebo, Calcium and Vitamin D
Year-1, 10 participants will take Alendronate (study medication)and calcium and vitamin D supplement).
Another 10 participants will take placebo, calcium and vitamin D. In year-2 they will crossover.
Those who took alendronate in the first year, will take Placebo, calcium and vitamin D for 12 months and those who took Placebo in the first year, will take Alendronate, calcium and vitamin D in the second year (12 months).
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Group-1/Year-1:Alendronate, pill, 35mg or 70mg, weekly; calcium, pill, 500mg or 1000mg daily; vitamin D, liquid, 800IU, daily, depending upon the body weight, for 12 months.
Group-1/Year-2:Placebo, pill, 35mg or 70mg, weekly; calcium, pill, 500mg or 1000mg daily; vitamin D, liquid, 800IU, daily, depending upon the body weight for 12 months.
Group-2/Year-1:Placebo, pill, 35mg or 70mg, weekly; calcium, pill, 500mg or 1000mg daily; vitamin D, liquid, 800IU, daily, depending upon the body weight for 12 months.
Group-2/Year-2: Alendronate, pill, 35mg or 70mg, weekly; calcium, pill, 500mg or 1000mg daily; vitamin D, liquid, 800IU, daily, depending upon the body weight for 12 months.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of Participants With Improvement in Bone Mineral Density (BMD) of Spine After Therapy
Time Frame: 12 months therapy
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Participants were screened for BMD of lumbar spine using DXA scan at visit 12 months after alendronate or placebo treatment.
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12 months therapy
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Number of Participants With Improvement in Bone Mineral Density (BMD) of Spine After Therapy
Time Frame: 24 months therapy
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BMD of lumbar spine was measured using DXA scan at visit 24 months (Year-2)after alendronate or placebo treatment.
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24 months therapy
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of Participants With Improvement in Bone Mineral Density (BMD) of Hip After Therapy
Time Frame: 12 months of therapy
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12 months of therapy
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Number of Participants With Improvement in BMD of Hip
Time Frame: 24 months of therapy
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Analysis was done per protocol and intention to treat.
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24 months of therapy
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Participants With Atraumatic Fractures
Time Frame: 0 months
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Number of Participants with Atraumatic fractures before therapy.
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0 months
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Participants With Atraumatic Fractures
Time Frame: 24 months
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Number of participants with fractures at the completion of therapy.
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24 months
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
October 1, 2003
Primary Completion (Actual)
March 1, 2008
Study Completion (Actual)
August 1, 2009
Study Registration Dates
First Submitted
November 29, 2005
First Submitted That Met QC Criteria
November 29, 2005
First Posted (Estimate)
December 1, 2005
Study Record Updates
Last Update Posted (Estimate)
January 19, 2011
Last Update Submitted That Met QC Criteria
December 29, 2010
Last Verified
December 1, 2010
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 5R01FD001847-05 (NIH)
- FDR00184705-83045-05 (Other Identifier: Medical University of South Carolina)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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