Alendronate in Juvenile Osteoporosis

NCT00920075 | Completed Results DMC

• 3 other identifiers: 5R01FD001847-05 REVISEDFD-R-001847-035R01FD001847-05
• Study Type: observational
• Target: 11
• Locations: 1 country
• Sites: 1

Brief Summary

The investigators earlier have shown that treatment of patients with juvenile osteoporosis with alendronate (Fosamax) for 12 months increased the bone density without side effects. In an open label study (10 patients) and double blind, crossover study (11 patients alendronate and 11 patients placebo), the investigators have further observed that alendronate increased the bone density significantly where as placebo (calcium and vitamin D) increased only minimally. These trials were completed. Thus, a post study is designed to evaluate the current status of the bone density and fractures after the patients discontinued the alendronate treatment. No treatment is involved.

Conditions

Juvenile Osteoporosis; Low Bone Density; Fractures

Keywords

Juvenile Osteoporosis; Bone Mineral Density; Fosamax; Dual Energy X-Ray Absorptiometry; Fracture

Outcome Measures

Primary Outcomes (1)

• Bone Mineral Density (BMD) of the Lumbar Spine (Participants With Percentage Increase).

  Participants who earlier completed in our open labeled or double blind study of alendronate treatment for juvenile osteoporosis, were invited for one clinical visit. Bone density of spine was measured by DXA scan.

  Post study (1-6 yrs), one clinical visit

Secondary Outcomes (2)

• Bone Mineral Density (BMD) of the Hip (Participants With Percentage Increase).

  Post study (1-6 years), one clincial visit

• Number of Participants With Fracture

  Post study (1-6 years), one clinical visit

Study Arms (1)

1 Alendronate for 12 months, post study

Participants earlier were treated with alendronate for 12 months either in an open label study (without control) or double blind study with placebo control. These studies were completed. In this post study evaluation, available participants will be scheduled for one clinic visit to assess their current status of the bone density and no treatment is involved.

Drug: Alendronate (Fosamax)

Interventions

Alendronate (Fosamax) DRUG

Pill, 35mg or 70mg depending upon the body weight for 12 months. This was given for participants during the open label or double blind study. Current study is a post study evaluation of the current status of bone density after the participants completed the study. In this post study, no treatment is involved.

Also known as: Fosamax

1 Alendronate for 12 months, post study

Eligibility Criteria

• Age: 8 Years - 21 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Available male and female children who have participated and Completed in our earlier open label or double blind clinical trial.

You may qualify if:

• Participated in our earlier clinical study;
• Completed the earlier open label or double blind study;
• Availability to participate in the post study;
• Male and female children who have earlier participated in our clinical trial; AND
• Parental consent (and patient assent after age 12 years) to participate in the study. Participant's consent for those who have completed 18 years of age and above at the time of clinic visit.

You may not qualify if:

• Not participated in our earlier clinical study;
• Not completed our earlier trials; OR
• Pregnancy.

Sponsors & Collaborators

• Medical University of South Carolina: lead
• FDA Office of Orphan Products Development: collaborator
• Merck Sharp & Dohme LLC: collaborator

Study Sites (1)

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

Location

Related Publications (1)

• Key LL Jr, Ries W, Madyastha P, Reed F. Juvenile osteoporosis: recognizing the risk. J Pediatr Endocrinol Metab. 2003 May;16 Suppl 3:683-6.

  PMID: 12795371 RESULT

Related Links

• Juvenile Osteoporosis Clinical Trial

MeSH Terms

Conditions

Juvenile osteoporosis; Bone Diseases, Metabolic; Fractures, Bone

Interventions

Alendronate

Condition Hierarchy (Ancestors)

Bone Diseases; Musculoskeletal Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Diphosphonates; Organophosphonates; Organophosphorus Compounds; Organic Chemicals

Results Point of Contact

• Title: Deborah A Bowlby, Asst.Professor, Pediatric Endocrinology
• Organization: Medical University of South Carolina

bowlbyd@musc.edu

843-792-6807

Study Officials

• Deborah A Bowlby, M.D.

  Medical University of South Carolina

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: OTHER
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: June 11, 2009
• First Posted: June 15, 2009
• Study Start: July 1, 2009
• Primary Completion: September 1, 2009
• Study Completion: October 1, 2010
• Last Updated: July 11, 2018
• Results First Posted: December 10, 2010

Record last verified: 2010-11

Locations

US (1)