Pharmacological Management of Osteoporosis in Postmenopausal Women

Publication Date: February 18, 2020
Last Updated: May 3, 2024

Treatment and Management

Who to Treat

1.1: Endocrine Society (ES) recommends treating postmenopausal women at high risk of fractures, especially those who have experienced a recent fracture with pharmacological therapies, since the benefits outweigh the risks. ( 1-H )
699

Bisphosphonates

2.1: In postmenopausal women at high risk of fractures, ES recommends initial treatment with bisphosphonates (alendronate, risedronate, zoledronic acid, and ibandronate) to reduce fracture risk. ( 1-H )

Technical Remark:

  • Ibandronate is not recommended to reduce nonvertebral or hip fracture risk.
699
2.2: In postmenopausal women with osteoporosis who are taking bisphosphonates, ES recommends that fracture risk be reassessed after 3-5 years, and women who remain at high risk of fractures should continue therapy, while those who are at low-to-moderate risk of fractures should be considered for a “bisphosphonate holiday.” ( 1-L )

Technical Remarks:

  • A bisphosphonate holiday is operationally defined as a temporary discontinuation of bisphosphonate for up to 5 years. This period may be longer depending on the BMD and clinical circumstances of the individual patient.
  • The evidence is stronger for retention of benefits during a holiday for alendronate and zoledronic acid where there are randomized extension trials.
  • A shorter reassessment period of 3 years is more appropriate for annual intravenous zoledronic acid (5 mg) based on evidence from RCTs showing residual effects after 3 years of annual use.
  • Once a bisphosphonate holiday is initiated, reassess fracture risk at 2- to 4-year intervals and consider reinitiating osteoporosis therapy earlier than the 5-year suggested maximum if there is a significant decline in BMD, an intervening fracture, or other factors that alter the clinical risk status.
699

Denosumab

3.1: In postmenopausal women with osteoporosis who are at high risk for osteoporotic fractures, ES recommends using denosumab as an alternative initial treatment. ( 1-H )

Technical Remarks:

  • The recommended dosage is 60 mg subcutaneously every 6 months.
  • The effects of denosumab on bone remodeling, reflected in bone turnover markers, reverse after 6 months if the drug is not taken on schedule. Thus, a drug holiday or treatment interruption are not recommended with this agent.
699
3.2: In postmenopausal women with osteoporosis who are taking denosumab, ES suggests that the fracture risk be reassessed after 5-10 years and that women who remain at high risk of fractures should either continue denosumab or be treated with other osteoporosis therapies. ( 2-VL )
699
3.3: In postmenopausal women with osteoporosis taking denosumab, administration of denosumab should not be delayed or stopped without subsequent antiresorptive (e.g., bisphosphonates, HT or SERM) or other therapy administered in order to prevent a rebound in bone turnover and to decrease the risk of rapid BMD loss and an increased risk of fracture. ( UGPS )
699

Teriparatide and Abaloparatide

4.1: In postmenopausal women with osteoporosis at very high risk of fracture, such as those with severe or multiple vertebral fractures, ES recommends teriparatide or abaloparatide treatment for up to two years for the reduction of vertebral and nonvertebral fractures. ( 1-M )
699
4.2: In postmenopausal women with osteoporosis who have completed a course of teriparatide or abaloparatide, ES recommends treatment with antiresorptive osteoporosis therapies to maintain bone density gains. ( 1-L )
699

Romosozumab

A.1: In postmenopausal women with osteoporosis at very high risk of fracture, such as those with severe osteoporosis (i.e., low T-score <-2.5 and fractures) or multiple vertebral fractures, we recommend romosozumab treatment for up to one year for the reduction of vertebral, hip, and nonvertebral fractures. ( 1-M )

Technical Remarks:

  • The recommended dosage is 210 mg monthly by subcutaneous injection for 12 months.
  • Women at high risk of cardiovascular disease and stroke should not be considered for romosozumab pending further studies on cardiovascular risk associated with this treatment. High risk includes prior myocardial infarction or stroke.
699
A.2: In postmenopausal women with osteoporosis who have completed a course of romosozumab, we recommend treatment with antiresorptive osteoporosis therapies to maintain bone mineral density gains and reduce fracture risk. ( 1-M )
699

Selective Estrogen Receptor Modulators

5.1: In postmenopausal women with osteoporosis at high risk of fracture and with the patient characteristics below, ES recommends raloxifene or bazedoxifene to reduce the risk of vertebral fractures.

( 1-H )

Patient Characteristics:

  • with a low risk of DVT, and
  • for whom bisphosphonates or denosumab are not appropriate, or
  • with a high risk of breast cancer
699

Menopausal Hormone Therapy and Tibolone

6.1: In postmenopausal women at high risk of fracture and with the patient characteristics below, ES suggests menopausal HT, using estrogen only in women with hysterectomy, to prevent all types of fractures. ( 2-M )
Patient Characteristics:
  • Under 60 years of age or <10 years past menopause
  • At low risk of DVT
  • Those in whom bisphosphonates or denosumab are not appropriate
  • With bothersome vasomotor symptoms
  • With additional climacteric symptoms
  • Without contraindications
  • Without prior myocardial infarction or stroke
  • Without breast cancer
  • Willing to take menopausal HT
699
6.2: In postmenopausal women with osteoporosis at high risk of fracture and with the patient characteristics below, ES suggests tibolone to prevent vertebral and nonvertebral fractures. ( 2-M )
Patient Characteristics:
  • Under 60 years of age or <10 years past menopause
  • With a low risk of DVT
  • Those in whom bisphosphonates or denosumab are not appropriate
  • With bothersome vasomotor symptoms
  • With additional climacteric symptoms
  • Without contraindications
  • Without prior myocardial infarction or stroke or high risk for cardiovascular disease
  • Without breast cancer
  • Willing to take tibolone
Technical Remark:
  • Tibolone is not available in the U.S. or Canada.
699

Calcitonin

7.1: In postmenopausal women at high risk of fracture with osteoporosis, ES suggests that nasal spray calcitonin be prescribed only in women who cannot tolerate raloxifene, bisphosphonates, estrogen, denosumab, tibolone, abaloparatide, or teriparatide or for whom these therapies are not considered appropriate. ( 2-VL )
699

Calcium and Vitamin D

8.1: In postmenopausal women with low BMD and at high risk of fractures with osteoporosis, ES suggests that calcium and vitamin D be used as an adjunct to osteoporosis therapies. ( 2-L )
699
8.2: In postmenopausal women at high risk of fracture with osteoporosis who cannot tolerate bisphosphonates, estrogen, selective estrogen response modulators, denosumab, tibolone, teriparatide, and abaloparatide, ES recommends daily calcium and vitamin D supplementation to prevent hip fractures. ( 1-M )
699

Monitoring

9.1: In postmenopausal women with a low BMD and at high risk of fractures who are being treated for osteoporosis, ES suggests monitoring the BMD by DXA at the spine and hip every 1 to 3 years to assess the response to treatment. ( 2-VL )

Technical Remark:

  • Monitoring BTMs (serum CTX for antiresorptive therapy or P1NP for bone anabolic therapy) is an alternative way of identifying poor response or nonadherence to therapy.
699

Recommendation Grading

Overview

Title

Pharmacological Management of Osteoporosis in Postmenopausal Women

Authoring Organization

Endocrine Society

Publication Month/Year

February 18, 2020

Last Updated Month/Year

October 8, 2024

Document Type

Guideline

External Publication Status

Published

Country of Publication

US

Document Objectives

The objective is to provide an update of the 2019 Pharmacological Management of Osteoporosis in Postmenopausal Women: An Endocrine Society Clinical Practice Guideline for the pharmacological management of osteoporosis in postmenopausal women using romosozumab.

Target Patient Population

All women with postmenopausal osteoporosis

Target Provider Population

Endocrinologists, OBGYNs, primary care providers and other clinicians caring for women with postmenopausal osteoporosis

Inclusion Criteria

Female, Adult, Older adult

Health Care Settings

Ambulatory

Intended Users

Nurse, nurse practitioner, physician, physician assistant

Scope

Diagnosis, Assessment and screening, Treatment, Management

Diseases/Conditions (MeSH)

D015663 - Osteoporosis, Postmenopausal, D010024 - Osteoporosis

Keywords

osteoporosis, low bone density, bone disorders, postmenopausal osteoporosis

Source Citation

Dolores Shoback, Clifford J Rosen, Dennis M Black, Angela M Cheung, M Hassan Murad, Richard Eastell, Pharmacological Management of Osteoporosis in Postmenopausal Women: An Endocrine Society Guideline Update, The Journal of Clinical Endocrinology & Metabolism, Volume 105, Issue 3, March 2020, Pages 587–594, https://doi.org/10.1210/clinem/dgaa048

Supplemental Methodology Resources

Technical Review, Systematic Review Document