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Trial record 6 of 6 for:    "osteoporosis-pseudoglioma syndrome" OR "juvenile osteoporosis"

Safety and Efficacy of Alendronate (Fosamax) in Children With Osteoporosis

This study has been completed.
Sponsor:
Collaborators:
Merck Sharp & Dohme Corp.
Information provided by:
Medical University of South Carolina
ClinicalTrials.gov Identifier:
NCT00259857
First received: November 29, 2005
Last updated: December 29, 2010
Last verified: December 2010
  Purpose

We have previously evaluated the safety and efficacy of Alendronate in 10 patients with juvenile osteoporosis during a 12-month clinical trial. We have documented that Alendronate improved BMD of the spine and hip without any major side effects. There were no additional fractures during therapy. The present study is designed to further evaluate the safety and efficacy of Alendronate in 20 children with juvenile osteoporosis using a double-blind, randomized, placebo-controlled, cross-over protocol.


Condition Intervention Phase
Osteoporosis
Drug: Alendronate
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: A Randomized, Double-Blind, Placebo-Controlled, Prospective, Cross-Over Phase II Clinical Trial to Determine the Safety and Efficacy of Alendronate (Fosamax) in Juvenile Osteoporosis (IND#60,017)

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Number of Participants With Improvement in Bone Mineral Density (BMD) of Spine After Therapy [ Time Frame: 12 months therapy ] [ Designated as safety issue: No ]
    Participants were screened for BMD of lumbar spine using DXA scan at visit 12 months after alendronate or placebo treatment.

  • Number of Participants With Improvement in Bone Mineral Density (BMD) of Spine After Therapy [ Time Frame: 24 months therapy ] [ Designated as safety issue: No ]
    BMD of lumbar spine was measured using DXA scan at visit 24 months (Year-2)after alendronate or placebo treatment.


Secondary Outcome Measures:
  • Number of Participants With Improvement in Bone Mineral Density (BMD) of Hip After Therapy [ Time Frame: 12 months of therapy ] [ Designated as safety issue: No ]
  • Number of Participants With Improvement in BMD of Hip [ Time Frame: 24 months of therapy ] [ Designated as safety issue: No ]
    Analysis was done per protocol and intention to treat.

  • Participants With Atraumatic Fractures [ Time Frame: 0 months ] [ Designated as safety issue: No ]
    Number of Participants with Atraumatic fractures before therapy.

  • Participants With Atraumatic Fractures [ Time Frame: 24 months ] [ Designated as safety issue: No ]
    Number of participants with fractures at the completion of therapy.


Enrollment: 22
Study Start Date: October 2003
Study Completion Date: August 2009
Primary Completion Date: March 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Alendronate, Calcium, Vitamin D
Crossover study. Year-1, 10 participants will take study medication, calcium and vitamin D supplements and other 10 participants will take placebo, calcium and vitamin D supplements. Year-2, they will crossover to the second arm of the study. Those who took study medication and supplements in year-1, will take placebo and supplements in the year-2, and those 10 participants who took placebo and supplements in the year-1, will take study medications and supplements in the year-2.
Drug: Alendronate
Group-1/Year-1:Alendronate, pill, 35mg or 70mg, weekly; calcium, pill, 500mg or 1000mg daily; vitamin D, liquid, 800IU, daily, depending upon the body weight, for 12 months. Group-1/Year-2:Placebo, pill, 35mg or 70mg, weekly; calcium, pill, 500mg or 1000mg daily; vitamin D, liquid, 800IU, daily, depending upon the body weight for 12 months. Group-2/Year-1:Placebo, pill, 35mg or 70mg, weekly; calcium, pill, 500mg or 1000mg daily; vitamin D, liquid, 800IU, daily, depending upon the body weight for 12 months. Group-2/Year-2: Alendronate, pill, 35mg or 70mg, weekly; calcium, pill, 500mg or 1000mg daily; vitamin D, liquid, 800IU, daily, depending upon the body weight for 12 months.
Other Names:
  • Fosamax
  • TUMS or Viactive
  • Drisdol or Calciferol
Placebo Comparator: 2 Placebo, Calcium and Vitamin D
Year-1, 10 participants will take Alendronate (study medication)and calcium and vitamin D supplement). Another 10 participants will take placebo, calcium and vitamin D. In year-2 they will crossover. Those who took alendronate in the first year, will take Placebo, calcium and vitamin D for 12 months and those who took Placebo in the first year, will take Alendronate, calcium and vitamin D in the second year (12 months).
Drug: Alendronate
Group-1/Year-1:Alendronate, pill, 35mg or 70mg, weekly; calcium, pill, 500mg or 1000mg daily; vitamin D, liquid, 800IU, daily, depending upon the body weight, for 12 months. Group-1/Year-2:Placebo, pill, 35mg or 70mg, weekly; calcium, pill, 500mg or 1000mg daily; vitamin D, liquid, 800IU, daily, depending upon the body weight for 12 months. Group-2/Year-1:Placebo, pill, 35mg or 70mg, weekly; calcium, pill, 500mg or 1000mg daily; vitamin D, liquid, 800IU, daily, depending upon the body weight for 12 months. Group-2/Year-2: Alendronate, pill, 35mg or 70mg, weekly; calcium, pill, 500mg or 1000mg daily; vitamin D, liquid, 800IU, daily, depending upon the body weight for 12 months.
Other Names:
  • Fosamax
  • TUMS or Viactive
  • Drisdol or Calciferol

Detailed Description:

Osteoporosis is an uncommon disease in children and early adolescents. Patients have a low bone mineral density, develop fractures with minimal or no trauma, and frequently have a negative family history. The disease results from either diminished bone formation or increased bone removal (resorption). No specific drug therapy has been recommended for juvenile osteoporosis. Alendronate (Fosamax) is effective in inhibiting bone resorption, increasing BMD and reducing fractures in adults with postmenopausal osteoporosis, but have not become established therapies in children. In the present study, we plan to evaluate the safety and efficacy of Alendronate in 20 patients with juvenile osteoporosis in a two-year period. This is a randomized, double-blind, placebo-controlled protocol. In the year-1, 10 patients will be assigned to receive Alendronate and 10 patients placebo. In the year-2, patients will be crossed over to the second arm of the study. Those who received Alendronate in the year-1, will receive placebo in the second year and vice verse. The patients will have 5 visits, the initial screening visit followed by 4 post therapy visits in a six-month interval. Measurements include DXA bone density scan of spine and hip, urinalysis and blood work.

  Eligibility

Ages Eligible for Study:   5 Years to 15 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Eligibility Criteria:

  • 5-15 yrs of age
  • Weighing 20 kg and more
  • History of multiple fractures
  • Tanner stage II or less
  • Osteoporosis by DXA.

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 percent).
  • Bone Mineral Density (BMD) determined by DXA sacn to confirm osteoporosis at a Z score greater than 2 SD (standard deviations) below the normal mean for age (Z score < -2 SD).
  • 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 = 20 kg and more.

Exclusion Criteria:

  • History of severe gastritis or reflux.
  • Abnormalities of the esophagus that delay emptying, such as strictures or achalasia
  • Marked kyphoscoliosis or the inability to sit or stand for at least 30 minutes
  • Hypersensitivity to bisphosphonates
  • Uncorrected hypocalcemia
  • History of gastric or duodenal ulcers
  • Renal dysfunction as indicated by serum Cr >1.5 mg/dl.
  • Liver dysfunction as indicated by serum SGPT > 2 times the upper limit for age or serum total bilirubin > 2.0 mg/dl.
  • Diagnosis of osteogenesis imperfecta, a family history of osteogenesis imperfecta, blue sclerae or deafness.
  • Diagnosis of active rickets or osteomalacia or serum bone alkaline phosphatase 2 times greater than normal for age.
  • Pregnancy
  • Anorexia Nervosa
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00259857

Locations
United States, South Carolina
Medical University of South Carolina
Charleston, South Carolina, United States, 29425
Sponsors and Collaborators
Medical University of South Carolina
Merck Sharp & Dohme Corp.
Investigators
Principal Investigator: Deborah A Bowlby, M.D. Medical University of South Carolina
  More Information

Publications:
Responsible Party: Deborah A Bowlby, MD, Assistant Professor, Medical University of South Carolina
ClinicalTrials.gov Identifier: NCT00259857     History of Changes
Other Study ID Numbers: 5 R01 FD001847-05, FDR00184705-83045-05
Study First Received: November 29, 2005
Results First Received: November 9, 2010
Last Updated: December 29, 2010
Health Authority: United States: Food and Drug Administration

Keywords provided by Medical University of South Carolina:
Fracture
Bone Mineral Density
DXA

Additional relevant MeSH terms:
Osteoporosis
Bone Diseases
Bone Diseases, Metabolic
Musculoskeletal Diseases
Alendronate
Ergocalciferols
Vitamin D
Vitamins
Bone Density Conservation Agents
Growth Substances
Micronutrients
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on November 27, 2014