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

Sponsor:	FDA Office of Orphan Products Development
Collaborator:	Medical University of South Carolina
Information provided by:	FDA Office of Orphan Products Development
ClinicalTrials.gov Identifier:	NCT00010439

Purpose

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.

Condition	Intervention	Phase
Osteoporosis	Drug: alendronate	Phase II

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Official Title:	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

Resource links provided by NLM:

MedlinePlus related topics: 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 at 12 months. [ Time Frame: at 12 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

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 ]

Enrollment:	10
Study Start Date:	September 2000
Study Completion Date:	October 2003
Primary Completion Date:	October 2003 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: 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.	Drug: alendronate Pill, 35mg or 70mg weekly, depending upon the body weight for 12 months.

Detailed Description:

PROTOCOL OUTLINE:

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

Eligibility

Ages Eligible for Study:	5 Years to 14 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00010439

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

Investigators

Study Chair:

L. Lyndon Key, Jr.

Medical University of South Carolina

More Information

Additional Information:

"Click here for more information about this study:" This link exits the ClinicalTrials.gov site

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.

Responsible Party:	Medical University of South Carolina ( L Lyndon Key, MD., Prof and Chairman )
Study ID Numbers:	199/15705, MUSC-FDR001847
Study First Received:	February 2, 2001
Last Updated:	December 26, 2007
ClinicalTrials.gov Identifier:	NCT00010439 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by FDA Office of Orphan Products Development:

arthritis & connective tissue diseases
idiopathic juvenile osteoporosis
rare disease

Additional relevant MeSH terms:

Musculoskeletal Diseases
Alendronate
Physiological Effects of Drugs
Osteoporosis

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

ClinicalTrials.gov processed this record on November 27, 2009