Alendronate in Juvenile Osteoporosis - Full Text View

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

Purpose

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.

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

Study Type:	Observational
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: Bone Density Fractures Minerals Osteoporosis

Drug Information available for: Alendronate Alendronate sodium Fosamax

U.S. FDA Resources

Further study details as provided by Medical University of South Carolina:

Primary Outcome Measures:

Bone Mineral Density (BMD) of the Lumbar Spine (Participants With Percentage Increase). [ Time Frame: Post study (1-6 yrs), one clinical visit ] [ Designated as safety issue: No ]
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.

Secondary Outcome Measures:

Bone Mineral Density (BMD) of the Hip (Participants With Percentage Increase). [ Time Frame: Post study (1-6 years), one clincial visit ] [ Designated as safety issue: No ]
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 hip was measured by DXA scan.
Number of Participants With Fracture [ Time Frame: Post study (1-6 years), one clinical visit ] [ Designated as safety issue: No ]
Participants who earlier completed in our open labeled or double blind study of alendronate treatment for juvenile osteoporosis, were invited for one clinical visit. Their bone densities of spine and hip were measured by DXA scan. During this visit, their fracture history was obtained.

Enrollment:	11
Study Start Date:	July 2009
Study Completion Date:	October 2010
Primary Completion Date:	September 2009 (Final data collection date for primary outcome measure)

Groups/Cohorts	Assigned Interventions
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) 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. Other Name: Fosamax

Groups/Cohorts

Assigned Interventions

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)

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.

Other Name: Fosamax

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 alendronate treatment (10 patients) for 12 months increased bone density without side effects. Subsequently, in a double blind, crossover study, we have further confirmed that alendronate treatment (11 patients) increased bone density significantly whereas, placebo (11 patients with calcium and vitamin D), increased the bone density only minimally. There were no side effects. These patients were treated with alendronate 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 fracture history in the above participants after the discontinuation (1-6 years) of alendronate 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
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.

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

Medical University of South Carolina

FDA Office of Orphan Products Development

Merck

Investigators

Principal Investigator:

Deborah A Bowlby, M.D.

Medical University of South Carolina

More Information

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:	Deborah A Bowlby, MD, Assistant Professor, Medical University of South Carolina
ClinicalTrials.gov Identifier:	NCT00920075 History of Changes
Other Study ID Numbers:	5R01FD001847-05 REVISED, FD-R-001847-03
Study First Received:	June 11, 2009
Results First Received:	November 9, 2010
Last Updated:	November 9, 2010
Health Authority:	United States: Food and Drug Administration

Keywords provided by Medical University of South Carolina:

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

Additional relevant MeSH terms:

Fractures, Bone
Osteoporosis
Wounds and Injuries
Bone Diseases, Metabolic
Bone Diseases

Musculoskeletal Diseases
Alendronate
Bone Density Conservation Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on February 09, 2012