Osteopenia Musculoskeletal Diseases Osteoporosis
Conditions
Interventions
Patients in the ossein-hydroxyapatite complex (OHC) arm took two tablets of OHC every 12 hours (830 mg OHC per tablet), by oral route, along three years.
Patients in the calcium carbo
Sponsors
Javier Haya Palazuelos
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1. Patients with an indication for the use of CC or OHC according to the investigator criteria. 2. Perimenopausal women between 40 and 50 years old. 3. Patients treated in an outpatient setting.
Exclusion criteria
Exclusion criteria: 1. Patients with severe osteopenia (diagnosed by DEXA, bone mineral density [BMD] = -2 standard deviation [SD] T-score) or osteoporosis (BMD = -2.5 SD T score) 2. Patients who were being treated with a drug that could have compromised bone metabolism such as: glucocorticoids, steroids, thyroid hormones, heparins (in long-term treatment), anticonvulsants, anovulatory drugs, hormone replacement therapy, lithium, chemotherapy, selective estrogen-receptor modulator (SERM), immunosuppressive therapy, and bisphosphonates. A minimal washout period of 6 months was established for any of the previous treatments prior to including the patient in the study. 3. Patients with severe hypercalcaemia or hypercalciuria. 4. Pregnant patients. 5. Concomitant diseases that could have affected bone metabolism: acromegaly, hyperthyroidism, primary hyperparathyroidism, anorexia nervosa, Cushing’s syndrome, rheumatoid arthritis, renal diseases, renal lithiasis, diabetes mellitus, and chronic liver disease. 6. Concomitant metabolic bone disease: osteomalacia, Paget’s disease. 7. Neoplastic disease developed in the last 5 years, with the exception of skin neoplasias treated with a radical treatment. 8. Known allergy to any compound of the study drugs. 9. Gastrointestinal disorders that could interfere with drug absorption. 10. Women with an expected difficult follow-up due to psychological, cognitive or social circumstances. 11. Patients with foreseen low compliance, difficult follow-up and/or poor collaboration, or with foreseen risk of withdrawal over a minimum period of 3 months due to dementia, alcoholism, terminal illness, etc.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Measured using patient interview at follow-up visits every 6 months for 3 years: 1. The number of patients with at least one adverse reaction 2. The severity of the adverse reaction. 3. The relationship of the adverse reaction with the study medication 4. The actions taken in response to the adverse reaction. 5. The outcome of the adverse reaction. 6. The duration of the adverse drug reaction | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Bone mineral density was measured by DEXA every 18 months. 2. BMI (kg/m2) was measured every 18 months. 3. The waist hip ratio (%) was measured every 18 months. 4. Lipid metabolism was measured using laboratory analytical data yearly. 5. Bone fractures taking place during the study period were registered at each 6-month follow-up visit. 6. Climacteric (menopausal) symptom changes were measured using the GEM scale every 18 months. 7. Treatment compliance was assessed by means of patient interview at each follow-up (every 6 months). | — |
Countries
Spain
Outcome results
None listed