Heartland Osteoporosis Prevention Study
Condition: Osteopenia
MeSH terms: Bone Diseases, Metabolic
Intervention: Calcium Carbonate; Vitamin D3; Risedronate; Bone-loading exercises
Intervention description: Used as daily supplement to ensure subject obtains 1200 mg of calcium per day (diet + supplement); Subjects will receive Vitamin D3 supplements to ensure serum level of Vitamin D is at least 30 ng/ml.; Risedronate 35 mg orally will be ingested weekly by subjects in Risedronate group.; Subjects will participate in bone loading exercises (weight-bearing and resistance) three times weekly at community YMCAs.
Intervention MeSH terms: Vitamin D; Cholecalciferol; Risedronic Acid; Calcium Carbonate; Calcium
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Randomized to 3 treatment groups: Calcium + vitamin D only; risedronate and calcium + vitamin D; bone building exercises and calcium + vitamin D
Masking: None (Open Label)
Enrollment: 276.0
Sex: Female
Minimum age: 19 Years
Healthy volunteers: No
Keywords: Low bone mass; Post-menopausal women; Bone mineral density; Bone structure; Bone turnover; Bone-loading exercises; calcium and vitamin D; risedronate

Summary:

      The purpose of this study is to identify the best way to prevent bone loss in the first years
      after menopause. The HOPS study will compare bone loss at 12 months in women: 1) who take
      calcium and vitamin D only; 2) who take calcium and vitamin D plus the medication
      "risedronate"; or 3) who take calcium and vitamin D plus participate in bone-loading
      exercises. Our central hypothesis is that improvements in bone health will be greater in
      women randomized to bone-loading exercises with calcium and vitamin D compared to women who
      take calcium and vitamin D only or women who take calcium and vitamin D plus risedronate.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Women who are in their first 5 years of menopause

          -  Have a T score between -1 and -2.49 at the femoral neck, total hip, or L1-L4 spine

          -  Be 19 years of age or older

          -  Have their health care provider's permission to enroll in the study.

        Exclusion Criteria:

          -  Have osteoporosis

          -  Have a 10 yr probability of hip fracture >3% or major fracture >20% based on results
             of the fracture risk assessment (FRAX) tool

          -  Currently take bisphosphonates, estrogen replacement therapy, glucocorticosteroids, or
             other drugs affecting bone

          -  Currently participate in a resistance training or high impact weight bearing exercise
             program three or more times weekly

          -  Weigh >300 lbs

          -  Have abnormal results for the following laboratory tests: serum 25(OH)D; serum
             creatinine; serum calcium; parathyroid hormone (PTH); thyroid stimulating hormone
             (TSH).

          -  Have Paget's disease, heart disease, uncontrolled hypertension, renal disease, or
             other concomitant conditions that prohibit participation in exercises, risedronate
             therapy, or use of CaD supplements.