For postmenopausal women with osteoporosis, combined treatment with teriparatide 40 μg and denosumab can increase spine and hip bone mineral density (BMD) more significantly than standard combination therapy, according to study results published in The Lancet Diabetes & Endocrinology.

The study included postmenopausal women (at least 36 months since last menses or since hysterectomy, with a follicle-stimulating hormone concentration of ≥40 mIU/mL) with osteoporosis (n=76). Participants were randomly assigned 1:1 to receive either teriparatide 20 μg (standard dose) or 40 μg (high dose) once daily by subcutaneous injection for 9 months. At 3 months, all participants were started on denosumab 60 mg every 6 months by subcutaneous injection for a duration of 12 months. Patients were aware of their assigned treatment, but the outcome assessors were masked.

The researchers measured areal BMD (aBMD) at 0, 3, 9, and 15 months. The primary end point was the percentage change in lumbar spine aBMD from baseline to 15 months. Secondary end points were change in aBMD at the hip, femoral neck, and distal radius. Participants who completed ≥1 study visit after baseline were included in the modified intention-to-treat analysis.

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Of 76 participants, 39 were randomly assigned to receive teriparatide 20 μg and 37 to receive teriparatide 40 μg. Of these patients, 69 completed ≥1 visit after baseline.

At 15 months of follow-up, participants in the teriparatide 40-μg group had a significantly greater increase in mean spine aBMD (17.5%±6.0%) compared with the teriparatide 20-μg group (9.5%±3.2%; P <.0001).

Women in the teriparatide 40-μg group also had a greater increase in mean femoral neck aBMD (6.8%±4.1% vs 4.3%±3.7%; P =.04) and mean total hip aBMD (6.1%±3.4% vs 3.9%±2.9%; P <.0001) compared with those in the teriparatide 20-μg group.

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Adverse events occurred in 77% (n=30) of participants in the teriparatide 20-μg group and in 78% (n=29) of those in the teriparatide 40-μg group. Of these, 7 women receiving teriparatide 20 μg and 5 women receiving teriparatide 40 μg experienced a serious adverse event. The most frequent adverse events included joint pain (38%; n=15), muscle cramp (38%; n=15), and fatigue (31%; n=12) in the teriparatide 20-μg group and fatigue (38%; n=14), nausea (43%; n=16), and joint pain (46%; n=17) in the teriparatide 40-μg group.

The generalizability of the results may be limited because of the predominantly white and relatively small study population.

“Considering that skeletal integrity cannot be fully restored in most patients with established osteoporosis at present, this 40 μg regimen is likely to provide benefits for women at the highest risk of fragility fracture,” the researchers wrote.

Disclosure: Several study authors declared affiliations with the pharmaceutical industry. Please see the original reference for a full list of authors’ disclosures.

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Tsai JN, Lee H, David NL, Eastell R, Leder BZ. Combination denosumab and high dose teriparatide for postmenopausal osteoporosis (DATA-HD): a randomised, controlled phase 4 trial [published online August 22, 2019]. Lancet Diabetes Endocrinol. doi:10.1016/ S2213-8587(19)30255-4