ABSTRACT
Objective
Target Population
Benefits, Harms, and Costs
Evidence
Validation Methods
Intended Audience
SUMMARY STATEMENTS
- 1Secondary causes of bone loss should be excluded before confirming the presence of postmenopausal osteoporosis (moderate).
- 2The Fracture Risk Assessment Tool (FRAX) can be used to evaluate 10-year fracture risk (high). Alternatively, the Canadian Association of Radiologists and Osteoporosis Canada (CAROC) assessment tool may be used to evaluate the 10-year fracture risk (moderate).
- 3Ensure patients with postmenopausal osteoporosis receive a calcium-enriched diet (1200 mg elemental calcium daily) and adequate vitamin D supplementation, aiming for a 25-hydroxyvitamin D level of 75–125 nmol/L (30–50 ng/mL) (high).
- 4Health care providers should treat all patients with osteoporosis at intermediate risk with a 10%–20% risk of major osteoporotic fracture over the next 10 years with pharmacologic therapy (high).
- 5Health care providers should treat all patients at high risk of fracture (with a ≥20% risk of MOF or ≥3% risk of hip fracture over the next 10 years with pharmacologic therapy (high).
- 6Health care providers should treat all patients at very high fracture risk (recent fracture within the past 12 months or multiple fragility fractures or major osteoporotic fracture risk >30% or hip fracture risk >4.5%) preferably with an anabolic agent followed by an antiresorptive agent (moderate).
- 7Patients taking bisphosphonates should be considered for a bisphosphonate drug holiday after 5 years of bisphosphonate therapy, if the fracture risk is intermediate and femoral neck T-score is better than –2.5 and in the absence of prior fragility fracture (moderate).
- 8Atypical femoral fractures are associated with long-term bisphosphonate therapy and are uncommon. It is important to ask about thigh or groin pain in patients on antiresorptive therapy and the antiresorptive therapy should be stopped in the presence of an atypical femoral fracture (moderate).
- 9Osteonecrosis of the jaw is a rare complication of antiresorptive therapy, and the incidence seen in patients prescribed antiresorptive therapy ranges from 1 in 10 000 to 1 in 100 000 patient-years (high).
- 10Romosozumab, teriparatide, or denosumab should not be stopped without replacing these agents with an antiresorptive agent in order to prevent declines in bone mineral density and bone strength following cessation of drug therapy. (high).
RECOMMENDATIONS
- 1All adults ≥65 years should be screened for increased fracture risk by clinical evaluation and bone mineral density assessment. Community-based screening in older women may be effective in reducing the incidence of hip fracture (conditional, moderate).
- 2In postmenopausal women <65 years, evaluate fracture risk clinically without bone mineral density assessment (FRAX without bone mineral density). A bone mineral density assessment should be considered for patients with diseases or drugs associated with an increased risk of fracture or in the presence of a prior fragility fracture (conditional, low). If the FRAX score for MOF without bone mineral density is >10%, a bone mineral density assessment should also be considered.
- 3All patients with osteoporosis should be treated. After a fragility fracture, the risk of a subsequent fracture is highest in the next 12–24 months (imminent fracture risk). Pharmacologic therapy should be initiated after a fragility fracture without delay. (strong, high).
- 4Bisphosphonates may be offered to patients with osteoporosis at an intermediate risk of fracture in the absence of contraindications, ideally for up to 5 years (strong, high). Fracture risk should be revaluated after 3 to 5 years of bisphosphonate therapy, and a drug holiday should be considered (strong, moderate).
- 5Denosumab may be offered for up to 10 years in patients at high or very high risk of fracture in the presence of a normal serum calcium (adjusted for albumin or ionized calcium), normal vitamin D, and estimated glomerular filtration rate (eGFR) >15 mL/min/1.73 m2. If denosumab is discontinued, it should be replaced with an alternative treatment option (strong, high).
- 6Romosozumab may be offered to those at high or very high risk of fracture for up to 1 year (strong, high). After 1 year of therapy, romosozumab should be followed by an antiresorptive agent (strong, moderate). Romosozumab is contraindicated in the presence of a recent myocardial infarction or stroke or for patients with a high risk for major adverse cardiovascular events.
- 7Teriparatide or abaloparatide (for up to 2 years) may be offered to patients with a high or very high risk of fracture and should be followed by an antiresorptive agent (strong, high). Teriparatide and abaloparatide are not advised in patients with a history of cancer, radiation exposure, hypercalcemia, or hyperparathyroidism.
- 8Raloxifene or bazedoxifene may be offered to postmenopausal women with an intermediate risk of fracture who are at increased risk of breast cancer and at low risk of thromboembolic disease (conditional, ungraded).
- 9Menopausal hormone therapy may be given to postmenopausal women experiencing menopausal symptoms at low, intermediate, or high fracture risk if they are under the age of 60 years, with no history of breast cancer or thromboembolic disease and at a low risk of cerebrovascular or cardiovascular disease (conditional, moderate).
- 10A daily weight-bearing exercise program, as well as a calcium-enriched diet with adequate vitamin D supplementation, are advised (strong, high). Limitation of alcohol intake and smoking cessation should also be emphasized (strong, moderate).
Keywords
ABBREVIATIONS:
AFF: (atypical femoral fracture), BMD: (bone mineral density), CAROC: (Canadian Association of Radiologists and Osteoporosis Canada assessment tool), DXA: (dual-energy X-ray absorptiometry), eGFR: (estimated glomerular filtration rate), FN: (femoral neck), FRAX: (Fracture Risk Assessment Tool), MACE (major adverse cardiovascular events), MHT: (menopausal hormone therapy), MOF: (major osteoporotic fracture), PTH: (parathyroid hormone), TBS: (trabecular bone score)Purchase one-time access:
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Subscribe to Journal of Obstetrics and Gynaecology CanadaREFERENCES
- The current economic burden of illness of osteoporosis in Canada.Osteoporos Int. 2016; 27: 3023-3032
- The care gap in diagnosis and treatment of women with a fragility fracture.Osteoporosis Int. 2008; 19: 79-86
- Menopause and Oseteoporosis Working Group. Osteoporosis in menopause.J Obstet Gynaecol Can. 2014; 36: 839-840
- American Association of Clinical Endocrinologists/American College of Endocrinology clinical practice guidelines for the diagnosis and treatment of postmenopausal osteoporosis—2020 update.Endocr Pract. 2020; 26: 1-46
- Pharmacological management of osteoporosis in postmenopausal women: An Endocrine Society* clinical practice guideline.J Clin Endocrinol Metab. 2019; 104: 1595-1622
- Pharmacological management of osteoporosis in postmenopausal women: An endocrine society guideline update.J Clin Endocrinol Metab. 2020; 105: 587-594
- Screening in the community to reduce fractures in older women (SCOOP): A randomised controlled trial.Lancet. 2018; 391: 741-747
- Effectiveness of a two-step population-based osteoporosis screening program using FRAX: The randomized risk-stratified osteoporosis strategy evaluation (ROSE) study.Osteoporosis Int. 2018; 29: 567-578
- The effect of a screening and treatment program for the prevention of fractures in older women: A randomized pragmatic trial.J Bone Miner Res. 2019; 34: 1993-2000
- Screening to prevent osteoporotic fractures.JAMA. 2018; 319: 2532
- FRAX® with and without bone mineral density.Calcif Tissue Int. 2012; 90: 1-13
- Worldwide uptake of FRAX.Arch Osteoporos. 2014; 9: 166
- High fracture probability with FRAX usually indicates densitometric osteoporosis: Implications for clinical practice.Osteoporosis Int. 2012; 23: 391-397
- Development of prognostic nomograms for individualizing 5-year and 10-year fracture risks.Osteoporosis Int. 2008; 19: 1431-1444
- External validation of the garvan nomograms for predicting absolute fracture risk: The tromsø study.PLoS ONE. 2014; 9e107695
- Predicting fracture risk in younger postmenopausal women: Comparison of the garvan and FRAX risk calculators in the women's health initiative study.J Gen Intern Med. 2019; 34: 235-242
- Validation of FRAX and the impact of self-reported falls among elderly in a general population: The HUNT study.Norway. Osteoporos Int. 2017; 28: 2935-2944
- Influence of fall related factors and bone strength on fracture risk in the frail elderly.Osteoporos Int. 2007; 18: 603-610
- A meta-analysis of trabecular bone score in fracture risk prediction and its relationship to FRAX.J Bone Miner Res. 2016; 31: 940-948
- The added value of trabecular bone score to FRAX® to predict major osteoporotic fractures for clinical use in Chinese older people: The Mr. OS and Ms. OS cohort study in Hong Kong.Osteoporosis International. 2017; 28: 111-117
- Simplified 10-year absolute fracture risk assessment: A comparison of men and women.J Clin Densitom. 2010; 13: 141-146
- Effects of teriparatide and risedronate on new fractures in post-menopausal women with severe osteoporosis (VERO): a multicentre, double-blind, double-dummy, randomised controlled trial.Lancet. 2018 Jan 20; 391: 230-240
- Romosozumab or Alendronate for Fracture Prevention in Women with Osteoporosis.N Engl J Med. 2017 Oct 12; 377: 1417-1427
- Determinants of short term fracture risk in patients with a recent history of low-trauma non-vertebral fracture.Bone. 2017 Dec; 105: 287-291
- Zoledronic acid and clinical fractures and mortality after hip fracture.N Engl J Med. 2007; 357: 1799-1809
- Effects of continuing or stopping alendronate after 5 years of treatment.JAMA. 2006; 296: 2927
- Comparison of the effects of three oral bisphosphonate therapies on the peripheral skeleton in postmenopausal osteoporosis: The TRIO study.Osteoporosis Int. 2014; 25: 2729-2741
- Managing osteoporosis in patients on long-term bisphosphonate treatment: Report of a task force of the American Society for Bone and Mineral Research.J Bone Miner Res. 2016; 31: 16-35
- 10 years of denosumab treatment in postmenopausal women with osteoporosis: Results from the phase 3 randomised FREEDOM trial and open-label extension.Lancet Diabetes Endocrinol. 2017; 5: 513-523
- Postmenopausal osteoporosis.N Engl J Med. 2016; 374: 254-262
- Continuing bisphosphonate treatment for osteoporosis — For whom and for how long?.N Engl J Med. 2012; 366: 2051-2053
- Role of bisphosphonate therapy in patients with osteopenia: A systemic review.Cureus. 2019;
- Fracture prevention with zoledronate in older women with osteopenia.N Engl J Med. 2018; 379: 2407-2416
- Multinational, placebo-controlled, randomized trial of the effects of alendronate on bone density and fracture risk in postmenopausal women with low bone mass: Results of the fosit study.Osteoporosis Int. 1999; 9: 461-468
- Effect of alendronate on risk of fracture in women with low bone density but without vertebral fractures:results from the fracture intervention trial.JAMA. 1998; 280: 2077
- Effects of risedronate on fracture risk in postmenopausal women with osteopenia.Osteoporosis Int. 2008; 19: 681-686
- Bisphosphonate drug holiday and fracture risk: A population-based cohort study.J Bone Miner Res. 2018; 33: 1252-1259
- Response of bone turnover markers to three oral bisphosphonate therapies in postmenopausal osteoporosis: The TRIO study.Osteoporosis Int. 2016; 27: 21-31
- Need for additional calcium to reduce the risk of hip fracture with vitamin D supplementation: Evidence from a comparative metaanalysis of randomized controlled trials.J Clin Endocrinol Metab. 2007; 92: 1415-1423
- Calcium plus vitamin D supplementation and risk of fractures: An updated meta-analysis from the National Osteoporosis Foundation.Osteoporosis Int. 2016; 27: 367-376
- Calcium plus vitamin d supplementation and the risk of fractures.N Engl JMed. 2006; 354: 669-683
- Alcohol intake as a risk factor for fracture.Osteoporos Int. 2005; 16: 737-742
- Smoking and fracture risk: a meta-analysis.Osteoporos Int. 2005; 16: 155-162
- Effects of ground and joint reaction force exercise on lumbar spine and femoral neck bone mineral density in postmenopausal women: a meta-analysis of randomized controlled trials.BMC Musculoskelet Disord. 2012; 13: 177
- Exercise and lumbar spine bone mineral density in postmenopausal women: a meta-analysis of individual patient data.J Gerontol A Biol Sci Med Sci. 2002 Sep; 57: M599-M604
- Positive association between 25-hydroxy vitamin d levels and bone mineral density: A population-based study of younger and older adults.Am J Med. 2004; 116: 634-639
- Prevalence of vitamin D inadequacy among postmenopausal north american women receiving osteoporosis therapy.J Clin EndocrinolMetab. 2005; 90: 3215-3224
- The 25(OH)D level needed to maintain a favorable bisphosphonate response is ≥33 ng/mL.Osteoporosis Int. 2012; 23: 2479-2487
- Treatment of vitamin D insufficiency in postmenopausal women.JAMA Intern Med. 2015; 175: 1612
- Annual high-dose oral vitamin D and falls and fractures in older women.JAMA. 2010; 303: 1815
- Vitamin D in adult health and disease: A review and guideline statement from Osteoporosis Canada.CMAJ. 2010; 182: E610-E6E8
- The role of dietary protein and vitamin D in maintaining musculoskeletal health in postmenopausal women: A consensus statement from the European Society for Clinical and Economic Aspects of Osteoporosis and Osteoarthritis (ESCEO).Maturitas. 2014; 79: 122-132
- Gastric and esophagus events before and during treatment of osteoporosis.Calcif Tissue Int. 2010; 86: 110-115
- European consensus statement on the diagnosis and management of osteoporosis in chronic kidney disease stages G4–G5d.Nephrol DialTransplant. 2021; 36: 42-59
- The effect of 3 versus 6 years of zoledronic acid treatment of osteoporosis: A randomized extension to the horizon-pivotal fracture trial (PFT).J Bone Miner Res. 2012; 27: 243-254
- Reassessment of fracture risk in women after 3 years of treatment with zoledronic acid: When is it reasonable to discontinue treatment?.J Clin Endocrinol Metab. 2014; 99: 4546-4554
- Effects of denosumab on fracture and bone mineral density by level of kidney function.J Bone Miner Res. 2011; 26: 1829-1835
- A single-dose study of denosumab in patients with various degrees of renal impairment.J Bone Miner Res. 2012; 27: 1471-1479
- Vertebral fractures after discontinuation of denosumab: A post hoc analysis of the randomized placebo-controlled FREEDOM trial and its extension.J Bone Miner Res. 2018; 33: 190-198
- Discontinuation of denosumab therapy for osteoporosis: A systematic review and position statement by ECTS.Bone. 2017; 105: 11-17
- Effect of abaloparatide vs placebo on new vertebral fractures in postmenopausal women with osteoporosis.JAMA. 2016; 316: 722
- Effect of parathyroid hormone (1-34) on fractures and bone mineral density in postmenopausal women with osteoporosis.N Engl J Med. 2001; 344: 1434-1441
- Sequential treatment of severe postmenopausal osteoporosis after teriparatide: Final results of the randomized, controlled European study of forsteo (EUROFORS)*.J Bone Miner Res. 2009; 24: 726-736
- Eighteen months of treatment with subcutaneous abaloparatide followed by 6 months of treatment with alendronate in postmenopausal women with osteoporosis: Results of the ACTIVExtend Trial.Mayo Clin Proc. 2017; 92: 200-210
- Importance of prompt antiresorptive therapy in postmenopausal women discontinuing teriparatide or denosumab: The denosumab and teriparatide follow-up study (data-follow-up).Bone. 2017; 98: 54-58
- Effects of teriparatide on hip and upper limb fractures in patients with osteoporosis: A systematic review and meta-analysis.Bone. 2019; 120: 1-8
- One year of alendronate after one year of parathyroid hormone (1–84) for osteoporosis.N Engl J Med. 2005; 353: 555-565
- Denosumab and teriparatide transitions in postmenopausal osteoporosis (the DATA-Switch study): Extension of a randomised controlled trial.Lancet. 2015; 386: 1147-1155
- Activextend: 24 months of alendronate after 18 months of abaloparatide or placebo for postmenopausal osteoporosis.J Clin Endocrinol Metab. 2018; 103: 2949-2957
- FRAME study: The foundation effect of building bone with 1 year of romosozumab leads to continued lower fracture risk after transition to denosumab.J Bone Miner Res. 2018; 33: 1219-1226
- Romosozumab treatment in postmenopausal women with osteoporosis.N Engl J Med. 2016; 375: 1532-1543
- Effects of romosozumab compared with teriparatide on bone density and mass at the spine and hip in postmenopausal women with low bone mass.J Bone Miner Res. 2017; 32: 181-187
- Romosozumab (sclerostin monoclonal antibody) versus teriparatide in postmenopausal women with osteoporosis transitioning from oral bisphosphonate therapy: A randomised, open-label, phase 3 trial.Lancet. 2017; 390: 1585-1594
- Reduction of vertebral fracture risk in postmenopausal women with osteoporosis treated with raloxifene: results from a 3-year randomized clinical trial.JAMA. 1999; 282: 637
- Effects of raloxifene on fracture risk in postmenopausal women: The raloxifene use for the heart trial.J Bone Miner Res. 2007; 23: 112-120
- Sustained efficacy and safety of bazedoxifene in preventing fractures in postmenopausal women with osteoporosis: Results of a 5-year, randomized, placebo-controlled study.Osteoporosis Int. 2012; 23: 351-363
- Efficacy of tissue-selective estrogen complex of bazedoxifene/conjugated estrogens for osteoporosis prevention in at-risk postmenopausal women.Fertil Steril. 2009; 92: 1045-1052
- Selective oestrogen receptor modulators in prevention of breast cancer: An updated meta-analysis of individual participant data.Lancet. 2013; 381: 1827-1834
- Effects of raloxifene on cardiovascular events and breast cancer in postmenopausal women.N Engl J Med. 2006; 355: 125-137
- A 7-year randomized, placebo-controlled trial assessing the long-term efficacy and safety of bazedoxifene in postmenopausal women with osteoporosis: Effects on bone density and fracture.Menopause. 2015; 22: 806-813
- Effects of tamoxifen vs raloxifene on the risk of developing invasive breast cancer and other disease outcomes:the nsabp study of tamoxifen and raloxifene (STAR) P-2 trial.JAMA. 2006; 295: 2727
- Effects of estrogen plus progestin on risk of fracture and bone mineral density: the women's health initiative randomized trial.JAMA. 2003; 290: 1729
- Hormonal replacement therapy reduces forearm fracture incidence in recent postmenopausal women — results of the danish osteoporosis prevention study.Maturitas. 2000; 36: 181-193
- Menopausal hormone therapy and health outcomes during the intervention and extended poststopping phases of the women's health initiative randomized trials.JAMA. 2013; 310: 1353
- Atypical subtrochanteric and diaphyseal femoral fractures: Second report of a task force of the American Society for Bone and Mineral Research.J Bone Miner Res. 2014; 29: 1-23
- Atypical femoral fracture.CMAJ. 2017; 189 (E542-E)
- Incidence of atypical nontraumatic diaphyseal fractures of the femur.J Bone Miner Res. 2012; 27: 2544-2550
- Atypical femoral fractures: A teaching perspective.Can Assoc Radiol J. 2015; 66: 102-107
- Bisphosphonate use and atypical fractures of the femoral shaft.N Engl J Med. 2011; 364: 1728-1737
- Responses to treatment with teriparatide in patients with atypical femur fractures previously treated with bisphosphonates.J Bone Miner Res. 2017; 32: 1027-1033
- Teriparatide improves bone quality and healing of atypical femoral fractures associated with bisphosphonate therapy.Bone. 2013; 52: 360-365
- Healing of bisphosphonate-associated atypical femoral fractures in patients with osteoporosis: A comparison between treatment with and without teriparatide.J Bone Miner Metab. 2015; 33: 553-559
- Diagnosis and management of osteonecrosis of the jaw: A systematic review and international consensus.J Bone Miner Res. 2015; 30: 3-23
- Case-based review of osteonecrosis of the jaw (ONJ) and application of the international recommendations for management from the International Task Force on ONJ.J Clin Densitom. 2017; 20: 8-24
Article info
Publication history
Footnotes
Disclosures: Statements were received from all authors. Dr. Khan receives research funds from Alexion, Amgen, Ascendis, Radius, Takeda and Ultragenyx. Dr. Wolfman has been on the advisory board for Pfizer, Astellas, and BioSyent. She has been a speaker for Bayer and Pfizer and has received an unrestricted grant from Pfizer. No other relationships or activities that could involve a conflict of interest were declared. All authors have indicated that they meet the journal's requirements for authorship.
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