Low-Dose Hormone Replacement Therapy and Alendronate for Osteoporosis

• Status: Terminated
• Trial end date: 2004-09-01
• Target enrollment: 0
• Participant gender: Female

Summary

Osteoporosis, a condition in which bones are fragile and break easily, is a major health problem for postmenopausal women. Research studies have shown that both estrogen/progestin replacement therapy (hormone replacement therapy, or HRT) and alendronate are effective in preventing and treating osteoporosis. However, because these drugs work in somewhat different ways, a combination of the two drugs might protect women from osteoporosis better than either drug alone. In this study we will test whether HRT and alendronate given together for 3.5 years to postmenopausal women with low bone mass will have a greater effect on bone than either HRT or alendronate given alone. We will also give every participant in this study calcium and vitamin D supplements.

• Phase: Phase 3
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
• Treatments: Alendronate; Estrogens; Hormones; Progestins

Criteria

Inclusion Criteria:

• Women at least 60 years of age.

• Good general health.

• Willingness to participate in this 3.5 year study.

• Ability to give informed consent.

• Ability to live independently and travel to the research center for visits (we will provide transportation on a limited basis).

• Spine bone mineral density (BMD) (L1-4) T-score between -1.0 and -2.5, or a hip T-score between -1.0 and -2.5. A T-score of -1.0 is equal to a bone mass of one standard deviation below the mean peak bone mass in healthy young adult women.

Exclusion Criteria:

• Any history of cancer except the following: (a) superficial basal or squamous cell carcinoma of the skin which has been completely resected or resolved by a topical chemotherapeutic agent, and (b) other malignancies treated curatively at least 10 years previously, without any evidence of recurrence.

• Abnormal transvaginal ultrasound that has not been investigated and cleared by endometrial biopsy.

• History of low-trauma hip or spine fracture previously diagnosed.

• Serious residuals from cerebral vascular disease.

• Diabetes mellitus, except for easily controlled, non-insulin dependent or insulin dependent diabetes mellitus without significant microvascular or neuropathic disease.

• Serum creatinine >1.9 mg/dl.

• Chronic liver disease or alcoholism.

• Treatment with bone active agents such as fluoride or bisphosphonates within the previous 2 years.

• Treatment with calcitonin, estrogen, or a selective estrogen receptor modulator within the previous 6 months.

• Systemic corticosteroid therapy at pharmacologic levels for more than 6 months duration.

• Any corticosteroid therapy within the previous 6 months.

• Treatment with anticonvulsant therapy within the previous year.

• Clinically significant abnormalities on pre-study laboratory or clinical screens.

• Treatment with thyroid hormone is accepted, provided the patient is euthyroid at the time of entry, and the serum TSH by ultrasensitive assay is normal.

• Uncontrolled hypertension.

• Unstable angina.

• Myocardial infarction within 1 year prior to entry.

• Evidence of metabolic bone disease, e.g. hyper- or hypoparathyroidism, Paget's disease, osteomalacia, osteogenesis imperfecta, or others.

• Active rheumatoid arthritis or collagen disease.

• Recent major gastrointestinal disease (within the past year) such as peptic ulcer, malabsorption, chronic ulcerative colitis, regional enteritis, or any significant chronic diarrhea state.

• Tobacco use at a level of more than 10 cigarettes per day.