Teriparatide
| Type | Recommendation |
|---|---|
| When to deprescribe | |
| CBR |
We suggest deprescribing decisions be made in consultation with the person and their specialist providers to ensure it aligns with their preferences, goals and overall treatment plans. We suggest deprescribing be offered to older people who have been taking teriparatide for 24 months or longer* due to the limited efficacy and safety data beyond 24 months of continuous treatment or reinitiation of treatment; however, the duration of therapy should be guided by individual factors and informed consent. * Teriparatide is approved for 24 months lifetime use in Australia with Pharmaceutical Benefits Scheme subsidisation for 18 months per lifetime per person. |
| Ongoing treatment | |
| CBR | For postmenopausal women and men discontinuing teriparatide, we suggest transitioning to bisphosphonate therapy for at least 12 months. If bisphosphonates are contraindicated or not tolerated, alternative antiresorptive therapy should be considered. |
| How to deprescribe | |
| CBR |
We suggest ceasing teriparatide without the need for tapering. |
| Monitoring | |
| CBR |
We suggest closely monitoring for fracture risk using the Fracture Risk Assessment Tool and/or bone turnover markers, and the need for restarting therapy for osteoporosis in people not receiving therapy at a high risk of fracture, such as at least monthly for the first six months after deprescribing, followed by monitoring every six months thereafter to maintain the therapeutic relationship while working on lifestyle optimisation to reduce falls and fracture risk through multifactorial approach (e.g. environmental changes, exercise, nutrition). We suggest assessing bone mineral density by using dual-energy X-ray absorptiometry for men and women once after 12 months of discontinuation of therapy. |
CBR, consensus-based recommendation
Teriparatide, a parathyroid hormone analogue, is used to treat osteoporosis by stimulating bone formation and increasing bone mineral density (BMD) [177]. Teriparatide has been shown to reduce the risk of vertebral and non-vertebral fractures [470]. A 2019 systematic review and meta-analysis also found that teriparatide significantly reduced hip fractures in people with osteoporosis after a median treatment duration of 18 months (range: 6 to 24 months) [471]. Additionally, a 2024 retrospective cohort study reported that the functional benefits of teriparatide may vary by sex, with more pronounced improvements observed in men compared to women [472].
Teriparatide is indicated for individuals with osteoporosis at very high risk of fracture, such as those with a T-score ≤ -3.0 (with or without a history of fragility fracture) or a T-score < -2.5 with a history of fragility fracture. It is also recommended for individuals whose osteoporosis is refractory to antiresorptive therapy [473]. In Australia, teriparatide is approved for a maximum lifetime duration of 24 months, with PBS subsidisation limited to 18 months per person, due to the lack of long-term safety data. While high-dose teriparatide has been associated with an increased risk of osteosarcoma in rats, this risk has not been reported in humans [474]. Caution is advised when using teriparatide in individuals with a history of urolithiasis, as it may exacerbate the condition, and in those with impaired kidney function. Another potential adverse effect is postural hypotension, which can increase the risk of falls in older people. Combination therapy with bisphosphonates or other antiresorptive agents is not recommended due to insufficient evidence supporting additional fracture risk reduction.
Refer to the narrative evidence summary, the GRADE Summary of Findings table in the guidelines, and the Technical Report for a complete presentation of the deprescribing evidence based on the GRADE framework (including other factors considered in developing the recommendations).
Following teriparatide discontinuation, transitioning to an antiresorptive agent, preferably a bisphosphonate, is recommended to maintain the BMD gains with teriparatide. For individuals who cannot tolerate bisphosphonates, denosumab or raloxifene (for females only) can be considered suitable alternatives [473]. The importance of post-teriparatide antiresorptive therapy is supported by multiple studies summarised below.
The 2005 Parathyroid Hormone and Alendronate (PaTH) trial randomised women who had received parathyroid hormone monotherapy for one year to either placebo (n=60) or alendronate (n=59) for an additional year [475]. Those who received alendronate experienced greater BMD gains at both the spine and hip compared to those who received no follow-up treatment.
The EUROFORS (EUROpean study of FORSteo) trial further supports the role of antiresorptive therapy in maintaining BMD after teriparatide discontinuation. The study compared continued teriparatide treatment for an additional year versus switching to raloxifene or placebo. Women who continued teriparatide for 24 months showed further BMD increases, while those who switched to raloxifene maintained their BMD. In contrast, individuals in the placebo group experienced BMD loss [476].
Additionally, an RCT investigating denosumab therapy after teriparatide discontinuation demonstrated benefits in increasing BMD at the spine, femoral neck, and total hip [477]
For those who discontinue teriparatide, it is important to continue close monitoring of fracture risk and the need for restarting therapy for osteoporosis, such as monthly for the first six months. Fracture risk can be monitored using the Fracture Risk Assessment Tool [478] and/or bone turnover markers using dual-energy X-ray absorptiometry (DXA) scan, ideally using the same densitometer for consistency [479].
As part of a multifactorial approach to fall and fracture prevention, it is also essential to address modifiable risk factors through other strategies. These may include nutritional review, environmental modifications and participating in fall prevention exercise programs, which have been shown to significantly reduce fall-related injuries, including fractures [480].
We identified one cohort study examining teriparatide deprescribing from the systematic review and meta-analysis [481]. The findings from the study suggest that postmenopausal women may require more urgent initiation of antiresorptive therapy following discontinuation of teriparatide due to more rapid bone loss in the spine, whereas men might be managed more conservatively with observation and closer monitoring. However, the reported outcome is very low in certainty due to a very small sample size and methodological limitations. The evidence at this stage is insufficient to inform evidence-based recommendations.
Key study characteristics and results
This study included 14 postmenopausal women and 17 eugonadal men with lumbar spine or femoral neck BMD T-scores below -2. Participants were provided 400 units of vitamin D daily, with calcium intake maintained between 1000 to 1200 mg daily through diet and/or supplements. Teriparatide therapy was discontinued after 24 months, in alignment with its approved duration due to safety concerns. At 12 months after discontinuation, there was a greater reduction in bone mass density in women than in men for spinal and trabecular BMD of the lumbar spine. BMD in the femoral neck and total hip remained stable for men.
The method of deprescribing was not specified in the study, but it appears to have involved abrupt discontinuation.