Phase 3
N=276
Heartland Osteoporosis Prevention Study
Osteopenia
Bottom Line
View on ClinicalTrials.gov: NCT02186600 ↗Enrolled (actual)
276
Serious AEs
0.0%
Results posted
Jun 2023
Primary outcome: Primary: Change in Bone Strength Index of the Distal Tibia Based on Randomization to Control, Risedronate, or Exercise Group. — 2098.7; 1993.3; 2001; 2105.89 mg^2/mm^4 — p=0.7
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Calcium Carbonate (Drug); Vitamin D3 (Drug); Risedronate (Drug); Bone-loading exercises (Behavioral)
- Age
- Adult, Older Adult · 19+ yrs
- Sex
- Female
- Sponsor
- University of Nebraska
- Primary completion
- Jun 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Bone Strength Index of the Distal Tibia Based on Randomization to Control, Risedronate, or Exercise Group. |
2098.7; 1993.3; 2001; 2105.89; 1997.32; 1987.42 | 0.7 |
| SECONDARY Change in Bone Mineral Density (BMD) at the Spine (L1-L4) Based on Randomization to Control, Risedronate, or Exercise Group. |
0.889; 0.892; 0.886; .887; .907; .878 | 0.01 sig |
| SECONDARY Change in Serum Measures of Bone Resorption (Serum NTx) Based on Randomization to Control, Risedronate, or Exercise Group. |
13.99; 14.31; 15.03; 12.16; 10.30; 13.36 | <0.007 sig |
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.
Data sourced from ClinicalTrials.gov (NCT02186600). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.