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Guidelines have changed. Managing osteoporosis in General Practice 

Guidelines have changed. Managing osteoporosis in General Practice  - Featured Image

Guidelines now recommend a bone anabolic for the first line osteoporosis treatment of patients at very high risk of fracture. For GPs, identifying these patients as soon as possible is now an important part of osteoporosis care.

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Osteoporosis-related fractures cost around $3.5 billion in 2023 and are estimated to increase to $4.9 billion per year by 2033. That’s a 38% increase over a 10-year period (here). For patients at very high fracture risk, choosing to treat with a bone anabolic prior to antiresorptive therapy rapidly and significantly reduces this risk of fracture and contributes to improved outcomes in bone health (here, here, here).
 
The treatment paradigm has changed
 
Historically, antiresorptive therapies have been the mainstay of treatment for all patients regardless of fracture risk (here, here). This paradigm has now changed. Treating osteoporosis should involve a risk-stratification approach to ensure that patients at very high fracture risk can be considered for initial treatment with a bone anabolic (here, here).

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Box 1: Identifying very high fracture risk patients (here, here)
The following patients are considered at very high fracture risk:
- T-score ≤–2.5 with recent hip or vertebral fracture, or
- T-score ≤–2.5 with ≥2 recent fragility fractures (one within 24 months), or
- Fracture while on anti-resorptive treatment, or
- Fracture while on glucocorticoids, androgen deprivation therapy or aromatase inhibitors, or
- Presence of clinical risk factors, such as corticosteroids, low BMI and recurrent falls,
or
- Multiple other risk factors such as non-modifiable and lifestyle factors (parent with hip fracture, malnutrition, smoking), 50+ years with other risk factors, 70+ years, early menopause, certain diseases such as rheumatoid arthritis or diabetes or some other medications
- FRAX major osteoporotic fracture risk ≥30%, or hip fracture risk ≥4.5%
 
Read the 2025 HBA position statement here
- The 2024 joint RACGP/HBA osteoporosis guidelines were updated in late 2025 by HBA including changing the BMD T-score for very high risk patients from –3.0 to –2.5 (here, here)
 


There is a short window of opportunity to optimise patient outcomes with bone anabolics: Choosing to initiate antiresorptive therapy before assessing fracture risk may preclude your very high fracture risk patient from receiving optimal first line treatment with a bone anabolic(herehere, here). Instead, these patients should be referred to a bone specialist who plays a critical role in confirming very high fracture risk status and initiating a bone anabolic where appropriate (herehere).
Bone anabolics work differently to antiresorptive therapies
 
Compared with traditional antiresorptive therapies, which work to slow bone loss, the bone anabolic romosozumab has a unique dual mode of action that builds new bone AND slows bone loss (Box 2) (here, here, here, here).

Box 2: Summary of osteoporosis treatments (here, here, here)

Builds new boneSlows bone loss
Romosozumab
Teriparatide
Abaloparatide
Antiresorptive therapies

Osteoporosis treatment sequence matters. Bone anabolics are recommended as 1st line treatment before antiresorptive therapy in very high risk patients
 
Osteoporosis is a chronic disease that requires lifelong treatment in most patients (here) and as such, sequential therapies are recommended to optimise bone health and reduce fractures across your patient’s lifespan (here). Initial therapy should be selected based on the probability of achieving treatment targets within a reasonable timeframe, especially for patients at very high fracture risk (here).
 
The evidence is clear – osteoporosis treatment sequence matters (here). By referring your patients for romosozumab before starting them on an antiresorptive, you can build bone rapidly first with romosozumab and maintain gains with an antiresorptive (here, here, here). A summary of two head-to-head clinical trials assessing the efficacy and safety of romosozumab is provided in Box 3.

Box 3: Building bone first is the standard of care for patients at very high fracture risk
The FRAME study (here)
73% reduction in the risk of new vertebral fractures vs placebo over 12 months, which was maintained after transitioning to denosumab (p<0.001; co-primary endpoint: cumulative incidence of new vertebral fractures at months 12 and 24) in post-menopausal women.
The ARCH study (here, here)
Treatment with one year of romosozumab before one year of alendronate was superior to alendronate alone with 48% RRR (ARR=5.7%, p <0.001) in new vertebral fractures at 24 months, 19% RRR in nonvertebral fractures (ARR=1.9%, p=0.04), and 38% RRR in hip fractures (1.2% ARR, p=0.02) in postmenopausal women at the primary analysis.
The safety profile of romosozumab has been well-established across four Phase 3 studies (here, here, here, here)
The most-common AEs occurring in ≥10% of patients (n=3858) treated with romosozumab in placebo-controlled clinical trials were nasopharyngitis, arthralgia and back pain (here).
- AEs leading to discontinuation were reported for 3.0% of subjects in the total romosozumab group and 2.6% of subjects in the placebo group (here).
-TRAEs were reported for 16.1% of subjects in the romosozumab group and 13.5% of subjects in the placebo group (here).
- In the ARCH study, an increase in major adverse cardiovascular events (positively adjudicated cardiovascular death, myocardial infarction or stroke: 2.5% [n=50/2040] vs 1.9% [n=38/2014] with alendronate) was observed. This imbalance was not observed in FRAME (here, here, here).

Key steps for GPs when managing osteoporosis
 
Pause: Bone anabolics, including EVENITY, are recommended as first line treatment for patients at very high fracture risk(here, here, here, here).


Assess: Before initiating osteoporosis treatment, assess if very high fracture risk indicators are present(here, here).

Refer: RACGP/HBA guidelines recommend considering referral to a bone specialist for a bone anabolic for those at very high fracture risk (here, here).

“romosozumab for first-line use in very high-risk patients, a paradigm shift in the treatment of osteoporosis is now applicable, ultimately offering better health outcomes for our patients.”

-Jasna Aleksova and Peter Ebeling. Read the complete article (here)


TGA indication: treatment of osteoporosis in postmenopausal women at high risk of fracture and to increase bone mass in men with osteoporosis at high risk of fracture(here).

PBS Information: Authority Required as treatment for severe established osteoporosis. Criteria Apply. Refer to PBS Schedule for full Authority


Refer to full Product Information before prescribing; available from Amgen Australia Pty Ltd, Ph: 1800 803 638 or at www.amgen.com.au/Evenity.PI.
 
For more information on EVENITY or to report an adverse event or product complaint involving romosozumab, please contact Amgen Medical Information on 1800 803 638 or visit www.amgenmedinfo.com.au.
 
▼ This medicinal product is subject to additional monitoring in Australia. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse events at www.tga.gov.au/reporting-problems.
 
EVENITY MINIMUM PRODUCT INFORMATION. INDICATIONS: Treatment of osteoporosis in postmenopausal women at high risk of fracture. Treatment to increase bone mass in men with osteoporosis at high risk of fracture. CONTRAINDICATIONS: Uncorrected hypocalcaemia. Hypersensitivity to romosozumab, CHO-derived proteins or any component. History of myocardial infarction (MI) or stroke. PRECAUTIONS: Assess cardiovascular risk factors (e.g. established cardiovascular disease, hypertension, hyperlipidaemia, diabetes mellitus, smoking, severe renal impairment, age) prior to treatment. A patient’s suitability for treatment should be based on individual benefit-risk assessment. Consider relative benefits and risks of treatment in patients at high cardiovascular risk. Instruct patients to watch for symptoms of MI and stroke and to seek prompt medical attention if symptoms occur. Discontinue use if MI or stroke occurs during therapy. Correct hypocalcaemia prior to initiating therapy. Monitor patients for signs and symptoms. Adequately supplement intake of calcium and vitamin D. Initiate appropriate therapy and discontinue use if anaphylactic or other clinically significant allergic reaction occurs. Evaluate patients for risk factors for osteonecrosis of the jaw (ONJ); use with caution in these patients. Consider discontinuation if ONJ occurs. Rare reports of atypical femoral fractures. ADVERSE EFFECTS: Very Common: viral upper respiratory tract infection and arthralgia. Common: hypersensitivity, rash, dermatitis, headache, cough, neck pain, muscle spasms, peripheral edema and injection site reactions. DOSAGE AND ADMINISTRATION: Subcutaneous injection of 210 mg, once every month for 12 doses. To administer 210 mg, give two subcutaneous injections. Ensure adequate intake of calcium and vitamin D. After completing therapy, transition to antiresorptive osteoporosis therapy. No dose adjustment required in the elderly or in renal impairment. PRESENTATION: Pre-filled syringe, supplied as a 2-pack. Minimum PI Version 3. Refer to full Product Information before prescribing – available from Amgen Australia Pty Ltd. Ph: 1800 803 638 or at www.amgen.com.au/Evenity.PI
 
Abbreviations: AE, adverse events; ARR, absolute risk reduction; BMD, bone mineral density; BMI, body mass index; FRAX, fracture risk assessment tool; GP, general practitioner; HBA, Healthy Bones Australia; PBS, Pharmaceutical Benefits Scheme; RACGP, Royal Australian College of General Practitioners; RRR, relative risk reduction; TGA, Therapeutic Goods Administration; TRAE, treatment-related adverse event.
 
 
EVENITY is a registered trademark of Amgen Australia Pty Ltd. ABN 31 051 057 428, Sydney NSW 2000. ©2026 Amgen Inc. All rights reserved. AUS-785-26-80016. Approved March 2026.

 
 

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