Phase II Study of Alendronate Sodium in Children With High-Turnover Idiopathic Juvenile Osteoporosis - Tabular View

Tracking Information

First Received Date ^ICMJE

February 2, 2001

Last Updated Date

December 26, 2007

Start Date ^ICMJE

September 2000

Primary Completion Date

October 2003 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Bone Mineral Density (BMD) of the lumbar spine and hip at 12 months. [ Time Frame: at 12 months ] [ Designated as safety issue: Yes ]

Original Primary Outcome Measures ^ICMJE

Bone Mineral Density (BMD) of the lumbar spine and hip at 12 months. [ Time Frame: at 12 months ]

Change History

Complete list of historical versions of study NCT00010439 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Fracture rate before and during therapy; bone biopsies and biochemical markers to determine whether or not the primary effect of therapy is on bone formation or resorption; bone biopsies will also be used to assess the safety. [ Time Frame: at 12 months ] [ Designated as safety issue: Yes ]

Original Secondary Outcome Measures ^ICMJE

Descriptive Information

Brief Title ^ICMJE

Phase II Study of Alendronate Sodium in Children With High-Turnover Idiopathic Juvenile Osteoporosis

Official Title ^ICMJE

A Non-Randomized, Open-Label, Prospective, Non-Controlled, 12-Month Clinical Trial to Determine the Effects of Alendronate 35 or 70 mg/Week Depending Upon Body Weight, in Children and Adolescent With IJO

Brief Summary

OBJECTIVES:

I. Determine the effects of alendronate sodium on skeletal remodeling and bone mineral density of the hip and spine in children with high-turnover idiopathic juvenile osteoporosis.

Detailed Description

PROTOCOL OUTLINE:

Patients receive oral alendronate sodium daily for 1 year. Treatment continues in the absence of disease progression or unacceptable toxicity.

Study Phase

Phase II

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study

Condition ^ICMJE

Osteoporosis

Intervention ^ICMJE

Drug: alendronate

Study Arms / Comparison Groups

Experimental: Ten children will take alendronate 35mg or 70mg weekly depending upon the body weight for 12 months. Patients will also take calcium suplement daily.

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

October 2003

Primary Completion Date

October 2003 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Eligibility Criteria:

5-14 years of age
Weight 20 kg or greater
History of one or more atraumatic fracture
Sexual development no greater than Tanner II
Osteoporosis by DXA (Diagnosis of high-turnover osteoporosis with no underlying cause (e.g., malignancy, hyperthyroidism, hyperparathyroidism, or vitamin D intoxication)

Inclusion Criteria:

Male and female children with a history of one or more atraumatic fractures, or evidence of one or more compression fractures on radiographs of the spine (reduction of >20%).
Bone mineral density by DXA at 2 standard deviations (SD) below normal mean for age (Z-score at least 2 SD below normal mean at the lumbar spine or hip)
Parental consent (and patient assent after age 12 years) to participate in the study.
Sexual development at Tanner stage II or less (Prepubertal stage)
Weight 20kg and more

Exclusion Criteria:

History of severe gastritis or reflux
Marked kyphoscoliosis or inability to sit or stand for at least 30 minutes.
Abnormalities of the esophagus that delay emptying (e.g., strictures or achalasia)
Hypersensitivity to bisphosphonates
Uncorrected hypocalcemia
History of gastric or duodenal ulcers
Renal dysfunction as indicated by serum Creatinine greater than 1.5 mg/dL
Liver dysfunction as indicated by serum SGPT greater than 2 times upper limit of normal for age or serum total bilirubin greater than 2.0 mg/dL
Diagnosis of osteogenesis imperfecta (including family history) or blue sclerae or deafness
Diagnosis of active rickets, osteomalacia, or bone alkaline phosphatase > 2 times normal for age
Severe gastritis or reflux
Pregnancy
Anorexia Nervosa
- Prior/Concurrent Therapy—
Prior course of prednisone allowed
No concurrent prednisone except inhaled steroids
No concurrent high-dose glucocorticoids
No concurrent salmon calcitonin
No other concurrent bisphosphonates
No concurrent long-term anti-seizure medication

Gender

Both

Ages

5 Years to 14 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT ID ^ICMJE

NCT00010439

Responsible Party

L Lyndon Key, MD., Prof and Chairman, Medical University of South Carolina

Study ID Numbers ^ICMJE

199/15705, MUSC-FDR001847

Study Sponsor ^ICMJE

FDA Office of Orphan Products Development

Collaborators ^ICMJE

Medical University of South Carolina

Investigators ^ICMJE

Study Chair:

L. Lyndon Key, Jr.

Medical University of South Carolina

Information Provided By

FDA Office of Orphan Products Development

Verification Date

December 2007

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP