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Nomegestrol acetate may enhance the skeletal effects of estradiol on biochemical markers of bone turnover in menopausal women after a 12-week treatment period.
Climacteric. 2005 Jun; 8(2):136-45.C

Abstract

OBJECTIVE

To compare the effects of a 12-week treatment with 17ss-estradiol given alone and in sequential combination with 3.75 mg of nomegestrol acetate (Naemis), or a placebo on biochemical markers of bone turnover in menopausal women.

PATIENTS AND METHODS

A double-blind, randomized, placebo and estradiol-controlled multicenter study was conducted. A total of 176 patients who had been menopausal for 1-10 years, hysterectomized or not, having no contraindications to hormone replacement therapy, without any risks factors for osteoporosis, received one of these treatments during 12 weeks: placebo, 1.5 mg estradiol (E(2)) or 1.5 mg E(2)/3.75 mg nomegestrol acetate (E(2)/NOMAC). The primary efficacy variables were the change in bone markers (total alkaline phosphatase, bone alkaline phosphatase and osteocalcin; urinary type-I collagen peptides).

RESULTS

The four biochemical markers decreased only in the E(2)/NOMAC group. Bone alkaline phosphatase, osteocalcin and urinary type-I collagen peptides decreased in the E(2) group. For both active treatment groups compared to the placebo group, the changes were statistically significant after a 12-week treatment. There were no statistically significant differences between the E(2) and the E(2)/NOMAC groups except for total serum alkaline phosphatase, whose mean value decreased in the E(2)/NOMAC group but increased slightly in the E(2) group (p < 0.001). Furthermore, after a 6-week treatment, the changes in biochemical markers of bone turnover were similar to those found after 12 weeks. Safety data were satisfactory with regard to estradiol given alone or in combination with nomegestrol acetate.

CONCLUSION

These results demonstrated that 1.5 mg E(2) is effective in reducing bone turnover in postmenopausal women and proved that the combination of 1.5 mg E(2) and 3.75 mg nomegestrol acetate has no deleterious effect on bone remodelling.

Authors+Show Affiliations

Laboratoire Théramex, Paris, France.No affiliation info availableNo affiliation info availableNo 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

16096169

Citation

Nguyên-Pascal, M L., et al. "Nomegestrol Acetate May Enhance the Skeletal Effects of Estradiol On Biochemical Markers of Bone Turnover in Menopausal Women After a 12-week Treatment Period." Climacteric : the Journal of the International Menopause Society, vol. 8, no. 2, 2005, pp. 136-45.
Nguyên-Pascal ML, Thomas JL, Bergougnoux L, et al. Nomegestrol acetate may enhance the skeletal effects of estradiol on biochemical markers of bone turnover in menopausal women after a 12-week treatment period. Climacteric. 2005;8(2):136-45.
Nguyên-Pascal, M. L., Thomas, J. L., Bergougnoux, L., Garnero, P., Drapier-Faure, E., & Delmas, P. D. (2005). Nomegestrol acetate may enhance the skeletal effects of estradiol on biochemical markers of bone turnover in menopausal women after a 12-week treatment period. Climacteric : the Journal of the International Menopause Society, 8(2), 136-45.
Nguyên-Pascal ML, et al. Nomegestrol Acetate May Enhance the Skeletal Effects of Estradiol On Biochemical Markers of Bone Turnover in Menopausal Women After a 12-week Treatment Period. Climacteric. 2005;8(2):136-45. PubMed PMID: 16096169.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Nomegestrol acetate may enhance the skeletal effects of estradiol on biochemical markers of bone turnover in menopausal women after a 12-week treatment period. AU - Nguyên-Pascal,M L, AU - Thomas,J L, AU - Bergougnoux,L, AU - Garnero,P, AU - Drapier-Faure,E, AU - Delmas,P D, PY - 2005/8/13/pubmed PY - 2006/2/10/medline PY - 2005/8/13/entrez SP - 136 EP - 45 JF - Climacteric : the journal of the International Menopause Society JO - Climacteric VL - 8 IS - 2 N2 - OBJECTIVE: To compare the effects of a 12-week treatment with 17ss-estradiol given alone and in sequential combination with 3.75 mg of nomegestrol acetate (Naemis), or a placebo on biochemical markers of bone turnover in menopausal women. PATIENTS AND METHODS: A double-blind, randomized, placebo and estradiol-controlled multicenter study was conducted. A total of 176 patients who had been menopausal for 1-10 years, hysterectomized or not, having no contraindications to hormone replacement therapy, without any risks factors for osteoporosis, received one of these treatments during 12 weeks: placebo, 1.5 mg estradiol (E(2)) or 1.5 mg E(2)/3.75 mg nomegestrol acetate (E(2)/NOMAC). The primary efficacy variables were the change in bone markers (total alkaline phosphatase, bone alkaline phosphatase and osteocalcin; urinary type-I collagen peptides). RESULTS: The four biochemical markers decreased only in the E(2)/NOMAC group. Bone alkaline phosphatase, osteocalcin and urinary type-I collagen peptides decreased in the E(2) group. For both active treatment groups compared to the placebo group, the changes were statistically significant after a 12-week treatment. There were no statistically significant differences between the E(2) and the E(2)/NOMAC groups except for total serum alkaline phosphatase, whose mean value decreased in the E(2)/NOMAC group but increased slightly in the E(2) group (p < 0.001). Furthermore, after a 6-week treatment, the changes in biochemical markers of bone turnover were similar to those found after 12 weeks. Safety data were satisfactory with regard to estradiol given alone or in combination with nomegestrol acetate. CONCLUSION: These results demonstrated that 1.5 mg E(2) is effective in reducing bone turnover in postmenopausal women and proved that the combination of 1.5 mg E(2) and 3.75 mg nomegestrol acetate has no deleterious effect on bone remodelling. SN - 1369-7137 UR - https://www.unboundmedicine.com/medline/citation/16096169/Nomegestrol_acetate_may_enhance_the_skeletal_effects_of_estradiol_on_biochemical_markers_of_bone_turnover_in_menopausal_women_after_a_12_week_treatment_period_ L2 - https://www.tandfonline.com/doi/full/10.1080/13697130500103433 DB - PRIME DP - Unbound Medicine ER -