The effect of low-dose continuous estrogen and progesterone therapy with calcium and vitamin D on bone in elderly women. A randomized, controlled trial

Robert R. Recker, K. Michael Davies, Rachel M. Dowd, Robert P. Heaney

Research output: Contribution to journalArticle

230 Citations (Scopus)

Abstract

Background: Hormone replacement therapy (HRT), the mainstay of osteoporosis prevention, is limited because of dose-related risks, side effects, and patient acceptance. The bone-sparing efficacy and tolerability of the lowest available doses of HRT have not been adequately studied in elderly women. Objective: To determine the bone-sparing effect of continuous low-dose HRT in elderly women. Design: Randomized, double-blind, placebo- controlled trial. Setting: University osteoporosis research and clinical center. Patients: 128 healthy white women (age > 65 years) with low bone mass recruited by word of mouth and by local advertisement. The principal eligibility criterion was spinal bone mineral density of 0.90 g/cm2 or less. Intervention: Continuous therapy with conjugated equine estrogen, 0.3 mg/d, and medroxyprogesterone, 2.5 mg/d, or matching placebo. Sufficient calcium supplementation was given to bring all calcium intakes above 1000 mg/d in both groups; supplemental oral 25-hydroxyvitamin D was given to maintain serum 25-hydroxyvitamin D levels of at least 75 nmol/L in both groups. Measurements: Bone mineral density of the spine, hip, total body, and forearm; serum total alkaline phosphatase and serum osteocalcin levels at 6- month intervals; and 24-hour urine creatinine and hydroxyproline excretion at baseline, 12 months, and 42 months. Results: During 3.5 years of observation, spinal bone mineral density increased by 3.5% (P <0.001) in an intention- to-treat analysis and by 5.2% among patients with greater than 90% adherence to therapy. Significant increases were seen in total-body and forearm bone density (P <0.01). Symptoms related to HRT (breast tenderness, spotting, pelvic discomfort, and mood changes) were mild and short-lived. Conclusions: Continuous low-dose HRT with conjugated equine estrogen and oral medroxyprogesterone combined with adequate calcium and vitamin D provides a bone-sparing effect that is similar or superior to that provided by other, higher-dose HRT regimens in elderly women. This combination is well tolerated by most patients.

Original languageEnglish
Pages (from-to)897-904
Number of pages8
JournalAnnals of Internal Medicine
Volume130
Issue number11
StatePublished - Jun 1 1999

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Hormone Replacement Therapy
Vitamin D
Progesterone
Estrogens
Randomized Controlled Trials
Calcium
Bone and Bones
Bone Density
Medroxyprogesterone
Conjugated (USP) Estrogens
Forearm
Osteoporosis
Therapeutics
Serum
Placebos
Metrorrhagia
Intention to Treat Analysis
Hydroxyproline
Osteocalcin
Alkaline Phosphatase

All Science Journal Classification (ASJC) codes

  • Medicine(all)

Cite this

The effect of low-dose continuous estrogen and progesterone therapy with calcium and vitamin D on bone in elderly women. A randomized, controlled trial. / Recker, Robert R.; Davies, K. Michael; Dowd, Rachel M.; Heaney, Robert P.

In: Annals of Internal Medicine, Vol. 130, No. 11, 01.06.1999, p. 897-904.

Research output: Contribution to journalArticle

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