Learning Objectives and CME/Disclosure Information

This activity is intended for healthcare providers delivering care to women and their families.

After completing this activity, the participant should be better able to:

1. Recall which postmenopausal women should be offered medical therapy to prevent fractures due to osteoporosis
2. Discuss the various pharmacologic options available to women at high risk of fractures due to osteoporosis

Estimated time to complete activity: 0.25 hours

Faculty:

Susan J. Gross, MD, FRCSC, FACOG, FACMG
President and CEO, The ObG Project

Disclosure of Conflicts of Interest

Postgraduate Institute for Medicine (PIM) requires instructors, planners, managers and other individuals who are in a position to control the content of this activity to disclose any real or apparent conflict of interest (COI) they may have as related to the content of this activity. All identified COI are thoroughly vetted and resolved according to PIM policy. PIM is committed to providing its learners with high quality CME activities and related materials that promote improvements or quality in healthcare and not a specific proprietary business interest of a commercial interest.

Faculty: Susan J. Gross, MD, receives consulting fees from Cradle Genomics, and has financial interest in The ObG Project, Inc.

Planners and Managers: The PIM planners and managers, Trace Hutchison, PharmD, Samantha Mattiucci, PharmD, CHCP, Judi Smelker-Mitchek, MBA, MSN, RN, and Jan Schultz, MSN, RN, CHCP have nothing to disclose.

Method of Participation and Request for Credit

Fees for participating and receiving CME credit for this activity are as posted on The ObG Project website. During the period from 7/1/2019 through 7/1/2021, participants must read the learning objectives and faculty disclosures and study the educational activity.

If you wish to receive acknowledgment for completing this activity, please complete the post-test and evaluation. Upon registering and successfully completing the post-test with a score of 100% and the activity evaluation, your certificate will be made available immediately.

For Pharmacists: Upon successfully completing the post-test with a score of 100% and the activity evaluation form, transcript information will be sent to the NABP CPE Monitor Service within 4 weeks.

Joint Accreditation Statement

In support of improving patient care, this activity has been planned and implemented by the Postgraduate Institute for Medicine and The ObG Project. Postgraduate Institute for Medicine is jointly accredited by the Accreditation Council for Continuing Medical Education (ACCME), the Accreditation Council for Pharmacy Education (ACPE), and the American Nurses Credentialing Center (ANCC), to provide continuing education for the healthcare team.

Physician Continuing Medical Education

Postgraduate Institute for Medicine designates this enduring material for a maximum of 0.25 AMA PRA Category 1 Credit(s)™. Physicians should claim only the credit commensurate with the extent of their participation in the activity.

Continuing Nursing Education

The maximum number of hours awarded for this Continuing Nursing Education activity is 0.2 contact hours.

Designated for 0.2 contact hours of pharmacotherapy credit for Advance Practice Registered Nurses.

Read Disclaimer & Fine Print

SUMMARY:

The Endocrine Society released guidance (2019) on the pharmacological management of osteoporosis and, based on evidence, recommends

…treating postmenopausal women at high risk of fractures, especially those who have experienced a recent fracture, with pharmacological therapies, as the benefits outweigh the risks

Definition of High Risk

• Definition of high risk
  • Prior spine or hip fracture or
  • BMD T-score of ≤−2.5 either the hip or spine or
  • 10-year hip fracture risk ≥3% or
  • Risk of major osteoporotic fracture ≥20%

Treatment Options

• Initial treatment for women at high risk of fractures: Bisphosphonates
  • Alendronate | Risedronate | Zoledronic acid | Ibandronate
  • Reassess fracture risk at 3 to 5 years
  • High risk should continue therapy while low-to-moderate risk may be candidates for ‘bisphosphonate holiday’
  • Ibandronate not recommended for nonvertebral or hip fracture risk reduction

Note: Osteonecrosis of the jaw (ONJ) and bisphosphonates: Absolute risk ranges from 1 in 10,000 to 1 in 100,000 | Higher risk in oncology setting | Risk may be as high as 21 in 10,000 if on medication >4 years | Increased risk with tooth extraction (0.5%)

• Alternative initial treatment: Denosumab
  • 60 mg subcutaneously every 6 months
  • Reassess risk at 5 to 10 years as to whether patient should remain on denosumab
• Consider SERMs (raloxifene or bazedoxifene)
  • Low risk of DVT and bisphosphonates/ denosumab not appropriate or
  • High risk of breast cancer
• Consider menopausal hormone therapy (estrogen only for women with hysterectomy) if
  • Cannot tolerate bisphosphonates/ denosumab or bisphosphonates/ denosumab not appropriate
  • <60 years of age or <10 years beyond menopause
  • Low risk of deep vein thrombosis | No contraindications | No previous history of MI or stroke | No breast cancer
  • Symptomatic vasomotor symptoms and/or other menopausal symptoms

Note: Tibolone may used based on the above clinical scenarios as well | Tibolone not currently available in the US or Canada)

• In women >60 who cannot tolerate bisphosphonates/ denosumab or bisphosphonates/ denosumab not appropriate, consider the following (in order)
  • SERM
  • HT or tibolone
  • Calcitonin
  • Calcium and vitamin D

Very High Risk of Fracture

Severe osteoporosis (ie, low BMD T-score <−2.5 and fractures) or multiple vertebral fractures

• Teriparatide and abaloparatide
  • These medications are parathyroid hormone and parathyroid hormone–related protein analogs
  • Anabolic agents that increase bone formation
  • Recommended for up to 2 years
  • Follow up using antiresorptive osteoporosis therapies to maintain gains
• Romosozumab
  • Monoclonal antibody that blocks sclerostin and increases new bone formation
  • Recommended for up to 1 year
  • Recommended dosage is 210 mg monthly by subcutaneous injection
  • Women at high risk of cardiovascular disease and stroke: Should not be considered for romosozumab

KEY POINTS:

• Calcitonin (nasal spray) may be an option only if patients can not tolerate or should not be prescribed the following
  • Raloxifene | Bisphosphonates | Estrogen | Denosumab | Tibolone | Abaloparatide | Teriparatide
• Calcium and vitamin D
  • Suggested adjunct to above therapies
  • Recommended supplementation if women can not tolerate medications
• Monitoring
  • Bone mineral density
    • Dual-energy X-ray absorptiometry at the spine and hip
    • Perform every 1 to 3 years
  • Bone turnover (alternative to determine poor response or treatment nonadherence)
    • Serum C-terminal crosslinking telopeptide for antiresorptive therapy or
    • Procollagen type 1 N-terminal propeptide for bone anabolic therapy
• Good bone health maintenance efforts are recommended for all postmenopausal women and include  
  • Adequate calcium and vitamin D intake
  • Resistance and balance exercises
  • Smoking cessation
  • Limited alcohol use
  • Decreased use of drugs
  • Optimization of comorbid conditions that can harm bone
• When choosing the best therapy
  • Multiple factors (e.g., costs, patient preferences, local guidance and drug availability etc.) will guide care
  • Individualize approach based on personalized risk/benefit

Learn More – Primary Sources:

Pharmacological Management of Osteoporosis in Postmenopausal Women: An Endocrine Society Clinical Practice Guideline

Pharmacological Management of Osteoporosis in Postmenopausal Women: An Endocrine Society Guideline Update

FDA approves new treatment for osteoporosis in postmenopausal women at high risk of fracture

Related ObG Topics:

USPSTF Recommendations: Screening for Osteoporosis to Prevent Fractures

ACP Releases Guidance Update on Osteoporosis Treatment

The SCOOP trial: Does Osteoporosis Screening Reduce Hip Fracture Rates in Older Women?

The VERO Trial Results: Teriparatide vs Risedronate for the Treatment of Osteoporosis