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Oral hormone therapy with 17beta-estradiol and 17beta-estradiol in combination with norethindrone acetate in the prevention of bone loss in early postmenopausal women: dose-dependent effects.
Menopause. 2005 Nov-Dec; 12(6):741-8.M

Abstract

OBJECTIVE

A 2-year multicenter, double-blind, randomized, placebo-controlled study examined the efficacy and safety of different doses of 17beta-estradiol (E(2)) alone and continuous-combined oral formulations of E(2) and norethindrone acetate (NETA) versus placebo in the prevention of bone loss in newly menopausal women.

DESIGN

Patients were randomized to one of seven groups: placebo, E(2) 0.25 mg, E2 0.5 mg, E(2) 1 mg, E(2) 1 mg/NETA 0.25 mg, E(2) 1 mg/NETA 0.5 mg, or E(2) 2 mg/NETA 1 mg. Treatment was a once-daily tablet taken for 26 months. The primary efficacy endpoint was the change in bone mineral density (BMD) at the lumbar spine, measured by dual-energy x-ray absorptiometry, at screening and at 13, 19, and 26 months. BMD changes at the femoral neck and trochanter were also assessed. Biochemical markers of bone metabolism were measured at baseline, and at 3, 6, 13, 19, and 26 months. Histological diagnoses of endometrial samples were tabulated for each treatment group.

RESULTS

A total of 327 women were randomized and 189 women completed the 2-year trial. BMD at the lumbar spine decreased 2.3% in the placebo group. The lowest dose of unopposed E(2) prevented bone loss at the spine and hip. Significant increases in spine BMD compared with placebo occurred in all groups of treatment with E(2) and were more pronounced in the combination groups. Compared with placebo, women receiving active treatment experienced greater reductions in bone resorption markers. The effects were evident by 6 months and generally remained stable thereafter. Adverse events, primarily associated with the endometrium, were the most common reasons for discontinuation.

CONCLUSIONS

There is a dose-dependent effect of E(2) on BMD. The addition of NETA seems to enhance the response in BMD observed with E(2). Low doses of E(2) (1 mg and lower) can be considered for the prevention of osteoporosis, while titrating the hormone dose to individual patient's needs.

Authors+Show Affiliations

Osteoporosis Medical Center, Annenberg Center for Health Sciences, Rancho Mirage, CA, USA. mgreen@dc.rr.comNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Journal Article
Multicenter Study
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

16278618

Citation

Greenwald, Maria W., et al. "Oral Hormone Therapy With 17beta-estradiol and 17beta-estradiol in Combination With Norethindrone Acetate in the Prevention of Bone Loss in Early Postmenopausal Women: Dose-dependent Effects." Menopause (New York, N.Y.), vol. 12, no. 6, 2005, pp. 741-8.
Greenwald MW, Gluck OS, Lang E, et al. Oral hormone therapy with 17beta-estradiol and 17beta-estradiol in combination with norethindrone acetate in the prevention of bone loss in early postmenopausal women: dose-dependent effects. Menopause. 2005;12(6):741-8.
Greenwald, M. W., Gluck, O. S., Lang, E., & Rakov, V. (2005). Oral hormone therapy with 17beta-estradiol and 17beta-estradiol in combination with norethindrone acetate in the prevention of bone loss in early postmenopausal women: dose-dependent effects. Menopause (New York, N.Y.), 12(6), 741-8.
Greenwald MW, et al. Oral Hormone Therapy With 17beta-estradiol and 17beta-estradiol in Combination With Norethindrone Acetate in the Prevention of Bone Loss in Early Postmenopausal Women: Dose-dependent Effects. Menopause. 2005 Nov-Dec;12(6):741-8. PubMed PMID: 16278618.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Oral hormone therapy with 17beta-estradiol and 17beta-estradiol in combination with norethindrone acetate in the prevention of bone loss in early postmenopausal women: dose-dependent effects. AU - Greenwald,Maria W, AU - Gluck,Oscar S, AU - Lang,Eva, AU - Rakov,Viatcheslav, Y1 - 2005/11/08/ PY - 2005/11/10/pubmed PY - 2007/2/6/medline PY - 2005/11/10/entrez SP - 741 EP - 8 JF - Menopause (New York, N.Y.) JO - Menopause VL - 12 IS - 6 N2 - OBJECTIVE: A 2-year multicenter, double-blind, randomized, placebo-controlled study examined the efficacy and safety of different doses of 17beta-estradiol (E(2)) alone and continuous-combined oral formulations of E(2) and norethindrone acetate (NETA) versus placebo in the prevention of bone loss in newly menopausal women. DESIGN: Patients were randomized to one of seven groups: placebo, E(2) 0.25 mg, E2 0.5 mg, E(2) 1 mg, E(2) 1 mg/NETA 0.25 mg, E(2) 1 mg/NETA 0.5 mg, or E(2) 2 mg/NETA 1 mg. Treatment was a once-daily tablet taken for 26 months. The primary efficacy endpoint was the change in bone mineral density (BMD) at the lumbar spine, measured by dual-energy x-ray absorptiometry, at screening and at 13, 19, and 26 months. BMD changes at the femoral neck and trochanter were also assessed. Biochemical markers of bone metabolism were measured at baseline, and at 3, 6, 13, 19, and 26 months. Histological diagnoses of endometrial samples were tabulated for each treatment group. RESULTS: A total of 327 women were randomized and 189 women completed the 2-year trial. BMD at the lumbar spine decreased 2.3% in the placebo group. The lowest dose of unopposed E(2) prevented bone loss at the spine and hip. Significant increases in spine BMD compared with placebo occurred in all groups of treatment with E(2) and were more pronounced in the combination groups. Compared with placebo, women receiving active treatment experienced greater reductions in bone resorption markers. The effects were evident by 6 months and generally remained stable thereafter. Adverse events, primarily associated with the endometrium, were the most common reasons for discontinuation. CONCLUSIONS: There is a dose-dependent effect of E(2) on BMD. The addition of NETA seems to enhance the response in BMD observed with E(2). Low doses of E(2) (1 mg and lower) can be considered for the prevention of osteoporosis, while titrating the hormone dose to individual patient's needs. SN - 1072-3714 UR - https://www.unboundmedicine.com/medline/citation/16278618/Oral_hormone_therapy_with_17beta_estradiol_and_17beta_estradiol_in_combination_with_norethindrone_acetate_in_the_prevention_of_bone_loss_in_early_postmenopausal_women:_dose_dependent_effects_ L2 - http://dx.doi.org/10.1097/01.gme.0000184425.73567.12 DB - PRIME DP - Unbound Medicine ER -