Safety and Efficacy of Alendronate (Fosamax) in Children With Osteoporosis
Condition: Osteoporosis
MeSH terms: Osteoporosis
Study type: Interventional
Phase: Phase 2

Summary: 
      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.
    

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.
    

Intervention name(s): Alendronate
Intervention type(s): Drug
Intervention description(s): 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 intervention name(s): Fosamax; TUMS or Viactive; Drisdol or Calciferol
Intervention MeSH terms: Alendronate
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Fracture; Bone Mineral Density; DXA