Treatment of Childhood Osteoporosis With Alendronate (Fosamax)

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Primary Purpose

Status

Completed

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

Alendronate

About this trial

This is an interventional treatment trial for Osteoporosis focused on measuring Glucocorticoids, Bone Mineral Density, Bisphosphonates, Vertebral Fracture, Childhood Osteoporosis

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

INCLUSION CRITERIA: 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. EXCLUSION CRITERIA: 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.

Sites / Locations

National Institute of Child Health and Human Development (NICHD)

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

NCT ID

NCT00001720

First Posted

November 3, 1999

Last Updated

September 21, 2016

Sponsor

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

1. Study Identification

Unique Protocol Identification Number

NCT00001720

Brief Title

Treatment of Childhood Osteoporosis With Alendronate (Fosamax)

Official Title

Alendronate Versus Placebo for Idiopathic Juvenile Osteoporosis

Study Type

Interventional

2. Study Status

Record Verification Date

September 2016

Overall Recruitment Status

Completed

Study Start Date

March 1998 (undefined)

Primary Completion Date

undefined (undefined)

Study Completion Date

June 2003 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor

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

4. Oversight

5. 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Osteoporosis

Keywords

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Enrollment

50 (false)

8. Arms, Groups, and Interventions

Intervention Type

Drug

Intervention Name(s)

Alendronate

10. Eligibility

Sex

All

Accepts Healthy Volunteers

No

Eligibility Criteria

INCLUSION CRITERIA: 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. EXCLUSION CRITERIA: 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.

Facility Information:

Facility Name

National Institute of Child Health and Human Development (NICHD)

City

Bethesda

State/Province

Maryland

ZIP/Postal Code

20892

Country

United States

12. IPD Sharing Statement

Citations:

PubMed Identifier

8374675

Citation

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

Results Reference

background

PubMed Identifier

9279333

Citation

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.

Results Reference

background

PubMed Identifier

8852571

Citation

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.

Results Reference

background

Osteoporosis

About this trial

Eligibility Criteria

Sites / Locations

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial