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

This study has been completed.

Sponsor:

Collaborator:

Merck

Information provided by:

Medical University of South Carolina

ClinicalTrials.gov Identifier:

NCT00010439

First received: February 2, 2001

Last updated: October 21, 2010

Last verified: October 2010

History of Changes

Tracking Information

First Received Date ^ICMJE

February 2, 2001

Last Updated Date

October 21, 2010

Start Date ^ICMJE

September 2000

Primary Completion Date

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

Current Primary Outcome Measures ^ICMJE

Number of Participants With Increased Bone Mineral Density [ Time Frame: at 12 months ] [ Designated as safety issue: No ]

Number of participants with increase in bone mineral density at Lumbar Spine and/or Hip at 12 months as compared to the bone mineral density at Lumbar Spine and/or Hip obtained before therapy (baseline values)

Original Primary Outcome Measures ^ICMJE

Not Provided

Change History

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

Current Secondary Outcome Measures ^ICMJE

Participants (1) With Fractures Before and After Therapy,(2)Analysed for Average Changes From High to Near Normal Mineral Apposition Rate (MAR) After Therapy,(3)Analysed for Average Insignificant Changes in Biochemical Markers After Therapy. [ Time Frame: Before and 12 months after treatment with alendronate ] [ Designated as safety issue: Yes ]

Participants (pts) with fractures bef.and aft.therapy; pts analysed for average changes in mineral apposition rate (MAR) (high (1.9um/day) to near normal (1.2 um/day)as revealed in bone biopsies. MAR is the distance between the two tetracycline labels (um/day). The data represent the average of 10-17 measurements of the disltance obtained by reading 2-7 individual slides of bone biopsy and pts analysed for average insignificant biochemical markers (serum bone specific alkaline phosphatase for bone formation and urinary N-telopeptide for resorption)to determine the effect of therapy.

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

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 weekly for 1 year. Treatment continues in the absence of disease progression or unacceptable toxicity.

Study Type ^ICMJE

Interventional

Study Phase

Phase 2

Study Design ^ICMJE

Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment

Condition ^ICMJE

Osteoporosis

Intervention ^ICMJE

Drug: Alendronate

Pill, 35mg or 70mg weekly, depending upon the body weight for 12 months.

Other Name: Fosamax

Study Arm (s)

Experimental: 1 Alendronate for 12 months

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

Intervention: Drug: Alendronate

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 2. P Madyastha, W Ries, B Hollis, F Reed, L Key. Alendronate improved bone mineral density in patients with juvenile osteoporosis. JBMR 20:Suppl 1, page S400, 2005.

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

November 2008

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 Number ^ICMJE

NCT00010439

Other Study ID Numbers ^ICMJE

199/15705, FD-R-001847-01

Has Data Monitoring Committee

Yes

Responsible Party

Deborah A Bowlby, MD., Assistant Professor, Medical University of South Carolina

Study Sponsor ^ICMJE

Medical University of South Carolina

Collaborators ^ICMJE

Merck

Investigators ^ICMJE

Principal Investigator:

Deborah A Bowlby, M.D.

Medical University of South Carolina

Information Provided By

Medical University of South Carolina

Verification Date

October 2010

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

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