Treatment of Childhood Osteoporosis With Alendronate (Fosamax)

NCT00001720 | Completed Phase 2

• 2 other identifiers: 98007798-CH-0077
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Osteoporosis

Keywords

Glucocorticoids; Bone Mineral Density; Bisphosphonates; Vertebral Fracture; Childhood Osteoporosis

Interventions

Alendronate DRUG

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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...).
• Hypocalcemia.
• 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.

Sponsors & Collaborators

• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): lead

Study Sites (1)

National Institute of Child Health and Human Development (NICHD)

Bethesda, Maryland, 20892, United States

Location

Related Publications (3)

• Bachrach LK. Bone mineralization in childhood and adolescence. Curr Opin Pediatr. 1993 Aug;5(4):467-73. doi: 10.1097/00008480-199308000-00017.

  PMID: 8374675 BACKGROUND

• Brumsen C, Hamdy NA, Papapoulos SE. Long-term effects of bisphosphonates on the growing skeleton. Studies of young patients with severe osteoporosis. Medicine (Baltimore). 1997 Jul;76(4):266-83. doi: 10.1097/00005792-199707000-00005.

  PMID: 9279333 BACKGROUND

• Falcini F, Trapani S, Ermini M, Brandi ML. Intravenous administration of alendronate counteracts the in vivo effects of glucocorticoids on bone remodeling. Calcif Tissue Int. 1996 Mar;58(3):166-9. doi: 10.1007/BF02526882.

  PMID: 8852571 BACKGROUND

MeSH Terms

Conditions

Osteoporosis; Spinal Fractures

Interventions

Alendronate

Condition Hierarchy (Ancestors)

Bone Diseases, Metabolic; Bone Diseases; Musculoskeletal Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases; Spinal Injuries; Back Injuries; Wounds and Injuries; Fractures, Bone

Intervention Hierarchy (Ancestors)

Diphosphonates; Organophosphonates; Organophosphorus Compounds; Organic Chemicals

Study Design

• Study Type: interventional
• Phase: phase 2
• Purpose: TREATMENT
• Sponsor Type: NIH

Study Record Dates

• First Submitted: November 3, 1999
• First Posted: November 4, 1999
• Study Start: March 1, 1998
• Study Completion: June 1, 2003
• Last Updated: September 22, 2016

Record last verified: 2016-09

Locations

US (1)