Study of Alendronate Sodium in Juvenile Osteoporosis - Full Text View

Sponsor:	FDA Office of Orphan Products Development
Collaborators:	Medical University of South Carolina Merck
Information provided by:	FDA Office of Orphan Products Development
ClinicalTrials.gov Identifier:	NCT00920075

Purpose

The investigators earlier have shown that treatment of patients with juvenile osteoporosis with alendronate sodium (Fosamax) for 12 months increased the bone density without side effects. In an open label study (10 patients) and double blind, crossover study (10 patients Fosamax and 10 patients placebo), the investigators have further observed that Fosamax 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 (continue to increase, decreased or unchanged) of the bone density and biomarkers after the patients discontinued the Fosamax treatment.

Condition	Intervention
Juvenile Osteoporosis Low Bone Density Fractures	Drug: Alendronate (Fosamax)

Study Type:	Interventional
Study Design:	Treatment, Open Label, Single Group Assignment, Safety/Efficacy Study
Official Title:	Phase II Study of Alendronate Sodium in Juvenile Osteoporosis (IND# 60,017)-Post Study Evaluation of Participants From Phase IIa and Phase IIb Clinical Study.

Resource links provided by NLM:

MedlinePlus related topics: Fractures Minerals Osteoporosis

Drug Information available for: Alendronate Alendronate sodium Fosamax

U.S. FDA Resources

Further study details as provided by FDA Office of Orphan Products Development:

Primary Outcome Measures:

Bone Mineral Density (BMD) of the Lumbar Spine and Hip. [ Time Frame: Post study ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Fractures, changes in biochemical markers [ Time Frame: Post study ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	25
Study Start Date:	June 2009
Estimated Study Completion Date:	September 2010
Estimated Primary Completion Date:	March 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1 Alendronate for 12 months, post study: Experimental 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 biomarkers and no treatment is involved.	Drug: Alendronate (Fosamax) 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 and biomarkers after the participant's completed the study. In this post study, no treatment is involved.

Arms

Assigned Interventions

1 Alendronate for 12 months, post study: Experimental

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 biomarkers and no treatment is involved.

Drug: Alendronate (Fosamax)

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 and biomarkers after the participant's completed the study. In this post study, no treatment is involved.

Detailed Description:

With the availability of Dual Energy X-ray Absorptiometry (DXA), juvenile osteoporosis has been recognized and diagnosed in recent years. The disease results from either diminished bone formation or increased bone removal (resorption) resulting in low bone density and fractures. No specific drug therapy has been recommended for juvenile osteoporosis. In an open label study, we earlier have shown that Fosamax treatment (10 patients) for 12 months increased bone density without side effects. Subsequently, in a double blind, crossover study, we have further confirmed that Fosamax treatment (10 patients) increased bone density significantly whereas, placebo (10 patients with calcium and vitamin D), increased the bone density only minimally. There were no side effects. There was an association between increased bone density and changes in biomarkers. These patients were treated with Fosamax only for 12 months and the clinical trials have been completed. We therefore, have designed a post study to evaluate the current status of the bone density and the biomarkers in the above participants after the discontinuation (1-6 years) of Fosamax treatment. Available participants, who have completed the earlier study, will be scheduled for a one time clinic visit. Measurements include DXA bone density measurement of spine and hip, urinalysis and blood work. No treatment is involved.

Eligibility

Ages Eligible for Study:	8 Years to 21 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

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.

Exclusion Criteria:

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00920075

Locations

United States, South Carolina
Medical University of South Carolina
Charleston, South Carolina, United States, 29425

Sponsors and Collaborators

FDA Office of Orphan Products Development

Medical University of South Carolina

Merck

Investigators

Principal Investigator:

Lyndon L Key, M.D.

Medical University of South Carolina

More Information

Additional Information:

Juvenile Osteoporosis Clinical Trial This link exits the ClinicalTrials.gov site

Publications:

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.

Responsible Party:	Medical University of South Carolina ( L Lyndon Key, MD, Prof and Chairman )
Study ID Numbers:	5R01FD001847-05 REVISED, FD-R-001847-03, FD-R01-2-0, FD-188-03
Study First Received:	June 11, 2009
Last Updated:	June 18, 2009
ClinicalTrials.gov Identifier:	NCT00920075 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by FDA Office of Orphan Products Development:

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

Additional relevant MeSH terms:

Musculoskeletal Diseases
Alendronate
Physiological Effects of Drugs
Osteoporosis, Postmenopausal
Osteoporosis

Bone Density Conservation Agents
Bone Diseases, Metabolic
Bone Diseases
Pharmacologic Actions

ClinicalTrials.gov processed this record on February 08, 2010