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Treatment of Childhood Osteoporosis With Alendronate (Fosamax)

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ClinicalTrials.gov Identifier: NCT00001720
Recruitment Status : Completed
First Posted : November 4, 1999
Last Update Posted : September 22, 2016
Information provided by:

Study Description
Brief Summary:

Bones grow and stay strong through a continuous process of formation (building) and resorption (break down). When more bone is formed than resorbed, the density (level of calcium) in bone increases and the bones become stronger. However, if more bone is resorbed than formed the density of bone decreases and the bones become weak. This condition is called osteoporosis.

Osteoporosis is a rare but serious condition in children. Childhood osteoporosis can occur without a known cause (idiopathic juvenile osteoporosis). Children with osteoporosis suffer from pain, inability to stay active, and increased amounts of broken bones, including fractures of the spine. Even mild childhood osteoporosis may have long-term consequences since individuals who achieve a less than normal bone composition (peak bone mass) during the first 20-30 years of life may be at an increased risk for osteoporosis as adults.

Alendronate (Fosamax) is a drug that works by stopping bone resorption (break down). It has been used to treat post-menopausal osteoporosis, male osteoporosis and adults with osteoporosis due to long-term steroid therapy. The goal of this study is to determine the effectiveness of alendronate in children with idiopathic juvenile osteoporosis. Researchers believe that children treated with alendronate will improve bone strength and decrease the amount of fractures caused by osteoporosis.

Condition or disease Intervention/treatment Phase
Osteoporosis Drug: Alendronate Phase 2

Detailed Description:

Osteoporosis is a rare but serious condition in children. One of the least well understood forms of childhood osteoporosis is idiopathic juvenile osteoporosis. Affected children suffer from pain, decreased activity tolerance, and increased fractures, including vertebral compression fractures. Even mild childhood osteoporosis may have long-term consequences since individuals who achieve a lower peak bone mass during the first 2-3 decades of life may be at increased risk for osteoporosis as adults.

Alendronate (Fosamax (Trademark), Merck & Co.), an aminobisphosphonate, is a potent inhibitor of bone resorption. It has been used to treat postmenopausal osteoporosis, idiopathic male osteoporosis, and glucocorticoid induced osteoporosis in adults. The goal of this protocol is to evaluate the effectiveness of Alendronate in children with glucocorticoid induced and idiopathic juvenile osteoporosis using a double-blind, randomized, placebo-controlled study design. We hypothesize that children treated with this drug will have an improvement in bone mineral density and decrease in osteoporotic fractures.

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Primary Purpose: Treatment
Official Title: Alendronate Versus Placebo for Idiopathic Juvenile Osteoporosis
Study Start Date : March 1998
Estimated Study Completion Date : June 2003

Arms and Interventions

Outcome Measures

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


Chronological age: 6.0 - 17.0 years. Study population will be restricted to children greater than 12 years of age until 8 patients have completed 6 months of the study or safety data is available from a comparable study.

AP Lumbar spine bone mineral density less than or equal to -2 standard deviations for age matched controls (z-score) using Hologic QDR machine.

Normative data published by Faulkner will be used to calculate Z-scores.

Patients with Idiopathic Juvenile Osteoporosis, osteoporosis (BMD less than -2 SD compared to age-matched controls) in a child with no identifiable etiology. Children with IJO and delayed puberty will have their z-score calculated on the basis of bone age.


Inability to swallow pills or comply with administration instructions.

Upper gastrointestinal tract disease.

Creatinine clearance greater than or equal to 35 mL per min per 1.73 square meters.

Prior treatment with bisphosphonates.

Concurrent therapy with oral aspirin or salicylate containing compounds, excluding delayed-release salicylates which act in the distal gastrointestinal tract (for example, mesalamine, sulfasalazine, etc...).


Treatment with hGH or calcitonin in the preceding 6 months.

Inability to undergo dual energy x-ray absorptiometry.

Positive pregnancy test.

In females, sexual activity without an effective method of contraception.

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00001720

United States, Maryland
National Institute of Child Health and Human Development (NICHD)
Bethesda, Maryland, United States, 20892
Sponsors and Collaborators
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
More Information

ClinicalTrials.gov Identifier: NCT00001720     History of Changes
Other Study ID Numbers: 980077
First Posted: November 4, 1999    Key Record Dates
Last Update Posted: September 22, 2016
Last Verified: September 2016

Keywords provided by National Institutes of Health Clinical Center (CC):
Bone Mineral Density
Vertebral Fracture
Childhood Osteoporosis

Additional relevant MeSH terms:
Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases
Metabolic Diseases
Bone Density Conservation Agents
Physiological Effects of Drugs