Low-Dose Hormone Replacement Therapy and Alendronate for Osteoporosis

NCT00000430 | Terminated Phase 3

• 2 other identifiers: N01 AR92237NIAMS-040
• Study Type: interventional
• Target: 240
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Osteopenia; Osteoporosis

Keywords

Osteoporosis; Osteopenia; Postmenopausal women; Hormone replacement therapy; Alendronate

Interventions

Alendronate DRUG

Estrogen/progestin therapy DRUG

Eligibility Criteria

• Age: 60 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS): lead

Study Sites (1)

Creighton University Osteoporosis Research Center

Omaha, Nebraska, 68131, United States

Location

MeSH Terms

Conditions

Bone Diseases, Metabolic; Osteoporosis

Interventions

Alendronate; Estrogens

Condition Hierarchy (Ancestors)

Bone Diseases; Musculoskeletal Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Diphosphonates; Organophosphonates; Organophosphorus Compounds; Organic Chemicals; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses

Study Officials

• Robert R. Recker, MD

  Creighton University Osteoporosis Research Center

  PRINCIPAL INVESTIGATOR

• Joan M. Lappe, PhD, RN

  Creighton University Osteoporosis Research Center

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: NIH

Study Record Dates

• First Submitted: January 18, 2000
• First Posted: January 19, 2000
• Study Start: October 1, 1999
• Study Completion: September 1, 2004
• Last Updated: January 4, 2007

Record last verified: 2004-02

Locations

US (1)