Efficacy of generic teriparatide and alendronate in Chinese postmenopausal women with osteoporosis: a prospective study

Abstract

Summary The efficacy of generic teriparatide in improving BMD at lumbar spine in patients with osteoporosis was similar to that of alendronate. It provided a new choice for osteoporosis treatment in Chinese population. Introduction To determine whether the efficacy of generic teriparatide is noninferior to alendronate for Chinese postmenopausal women with osteoporosis. Methods Eligible patients were randomly assigned (2:1) in a 48-week, open-label design to receive 20 µg sc daily teriparatide or 70 mg oral weekly alendronate. Primary outcome was percentage change in BMD at the lumbar spine from baseline to 48 weeks and was assessed for non-inferiority. The same outcome was further assessed for superiority as a secondary endpoint. Results Three hundred ninety-one and 196 participants were randomly assigned to the teriparatide or alendronate group, of whom 379 and 194 receiving at least one dose of teriparatide and alendronate treatment were eligible for the efficacy analysis. Teriparatide was non-inferior to alendronate for BMD change at lumbar spine (treatment difference: 0.7%, 95% CI: − 0.3 to 1.7%), which excluded the predefined non-inferiority margin of − 1.5%. However, teriparatide was not statistically superior to alendronate in improving BMD at lumbar spine (P = 0.169). At 48 weeks, changes in BMD at total hip were − 1.0% and 2.2% in teriparatide and alendronate group, respectively (P < 0.001). The incidence of new fracture showed no statistical difference between groups (P = 0.128). Serum P1NP and β-CTX levels significantly increased in the teriparatide group and markedly decreased in alendronate group (all P < 0.001 vs baseline). The adverse events (AEs) and serious AEs were more common in the teriparatide group than in the alendronate group, which were mainly teriparatide-related hypercalcemia, elevated alkaline phosphatase or parathyroid hormone, dizziness, and arthralgia. Conclusions Teriparatide was not inferior to alendronate in increasing BMD at lumbar spine in Chinese postmenopausal women, and they achieved these effects through different mechanisms.

Insights and implications of sexual dimorphism in osteoporosis

“… 459 Teriparatide and abaloparatide may cause hypercalcemia and hypercalciuria; therefore, preexisting hypercalcemia, hypercalciuria, and a history of kidney stones are considered contraindications for the use of these drugs. 460 , 461 …”

Effects of alendronate on cartilage lesions and micro-architecture deterioration of subchondral bone in patellofemoral osteoarthritic ovariectomized rats with patella-baja

“…Due to its role in regulating bone metabolism and anti-bone resorption, ALN is mainly used in the treatment of osteoporosis in clinical practice, especially for postmenopausal osteoporosis [ 43 ]. Early prophylactic treatment with sodium alendronate in the course of OA disease can reduce the metabolic rate of SB and alleviate the degeneration of articular cartilage, while late administration has no significant effect on articular cartilage, indicating that early treatment to protect SB has a positive role in preventing cartilage destruction [ 44 ].…”

Association Between CTSK Gene Polymorphisms and Response to Alendronate Treatment in Postmenopausal Chinese Women with Low Bone Mineral Density

“…Some scholars have detected the coding genes of seven key enzymes in the mevalonate pathway, including Mevalonate kinase (MK), Phosphomevalonate kinase (PMVK), Mevalonate decarboxylase (MVD), Isopentenyl pyrophosphate isomerase (IPI), Geranylgeranyl pyrophosphate synthase 1 (GGPS1), Farnesyl pyrophosphate synthase (FDPS) and Farnesyl-Diphosphate Farnesyltransferase 1 (FDFT1), and three genes of OPG/RANKL/RANK system, a total of 67 tag SNPs, and found that the response to alendronate is significantly associated with the patient’s genetic background. 6–11 Some enzymes in other pathways of bone metabolism also showed high correlation, such as SOST. 6 …”