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Clinical trial on alendronate sodium combined with teriparatide in the treatment of patients with postmenopausal osteoporosis patients
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Yan ZHU1a, Lei-yu QIU1b, Huan-xing LU1a
Chinese Journal of Clinical Pharmacology | 2025, 41(1) : 26 - 30
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Chinese Journal of Clinical Pharmacology | 2025, 41(1): 26-30
Clinical and Basic Bridging Research
Clinical trial on alendronate sodium combined with teriparatide in the treatment of patients with postmenopausal osteoporosis patients
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Yan ZHU1a, Lei-yu QIU1b, Huan-xing LU1a
Affiliations
  • 1a.Department of Spinal Surgery, Zhuji People’s Hospital of Zhejiang Province, Zhuji 311800, Zhejiang Province, China
  • 1b.Department of Medical Imaging, Zhuji People’s Hospital of Zhejiang Province, Zhuji 311800, Zhejiang Province, China
Published: 2025-01-17 doi: 10.13699/j.cnki.1001-6821.2025.01.006
Outline
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Objective

To explore the clinical efficacy and safety of alendronate sodium tablet combined with injection of recombinant teriparatide and calcium carbonate D3 tablet in the treatment of postmenopausal osteoporosis (PMDP).

Methods

The patients with postmenopausal osteoporosis were divided into control group and treatment group according to the cohort method according to the treatment regimen. The control group was treated with calcium carbonate D3 tablet (600 mg, 1 tablet a day) and alendronate sodium tablet (70 mg, once a week), while the treatment group was given injection of reacombinant teriparatide (200 U/20 μg, 20 μg every day) on the basis of the control group. Both groups were continuously treated for 6 months. The clinical efficacy was compared after 6 months of treatment. The bone mineral density (BMD) of lumbar spine, total hip and femoral neck and levels of bone metabolism indicators [osteocalcin (OCN), tartrate-resistant acid phosphatase-5b (TRAP-5b), procollagen type Ⅰ amino-terminal propeptide (PINP), C-terminal cross-linked peptide of type Ⅰ collagen (CTX-Ⅰ)]before treatment and after 6 months of treatment and bone pain [visual analogue scale (VAS)]and quality of life [European Foundation Osteoporosis Quality of Life Questionnaire (ECOS-16)]before treatment and after 3 and 6 months of treatment were recorded, and the adverse drug reactions within 6 months of treatment were compared.

Results

Fifty-two cases in treatment group and 64 cases in control group were enrolled. After treatment, the total effective rates in treatment group and control group were 87.80% (36 cases/41 cases) and 68.29% (28 cases/41 cases), respectively (P<0.05). The BMD values of lumbar spine in treatment group and control group after treatment were (0.69±0.15) and (0.79±0.18) g·cm-2; the BMD values of total hip were (0.70±0.11) and (0.77±0.15) g·cm-2; the BMD values of femoral neck were (0.79±0.19) and (0.87±0.15) g·cm-2, respectively; the OCN levels were (7.42±1.53) and (5.37±1.16) μg·L-1; the PINP levels were (85.31±5.66) and (76.30±5.49) ng·mL-1; the TRAP-5b levels were (3.27±0.46) and (5.16±0.72) U·L-1; the CTX-I levels were (3.37±0.54) and (5.08±0.70) ng·mL-1; the VAS scores were (1.48±0.13) and (2.07±0.24) points; the ECOS-16 scores were (24.84±4.62) and (32.71±6.07) points, and there were statistical differences in the above indicators between treatment group and control group (all P<0.05). The main adverse drug reactions in treatment group were rash, dizziness and limb pain, and the main adverse drug reactions in control group were rash, dizziness, nausea, and limb pain, and the total incidence rates of adverse reactions in treatment group and control group were 12.20% (5 cases/41 cases) and 19.51% (8 cases/41 cases) (P>0.05).

Conclusion

Alendronate sodium tablet combined with injection of recombinant teriparatide and calcium carbonate D3 tablet has a significant short-term efficacy on PMOP patients, and it can help to enhance the bone mineral density, reduce the symptoms of bone pain, and relieve the osteoporosis.

alendronate sodium tablet  /  injection of recombinant teriparatide  /  calcium carbonate D3 tablet  /  postmenopausal osteoporosis  /  clinical efficacy  /  safety
Yan ZHU, Lei-yu QIU, Huan-xing LU. Clinical trial on alendronate sodium combined with teriparatide in the treatment of patients with postmenopausal osteoporosis patients[J]. Chinese Journal of Clinical Pharmacology, 2025 , 41 (1) : 26 -30 . DOI: 10.13699/j.cnki.1001-6821.2025.01.006
Year 2025 volume 41 Issue 1
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doi: 10.13699/j.cnki.1001-6821.2025.01.006
  • Receive Date:2024-02-20
  • Online Date:2026-08-04
  • Published:2025-01-17
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History
  • Received:2024-02-20
Affiliations
    1a.Department of Spinal Surgery, Zhuji People’s Hospital of Zhejiang Province, Zhuji 311800, Zhejiang Province, China
    1b.Department of Medical Imaging, Zhuji People’s Hospital of Zhejiang Province, Zhuji 311800, Zhejiang Province, China
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表12种不同金属材料的力学参数

Family
属数
Number of
genus
种数
Number of
species
占总种数比例
Percentage of
total species (%)

Genus
种数
Number of
species
占总种数比例
Percentage of total
species (%)
鹅膏菌科Amanitaceae 2 11 5.26 鹅膏菌属 Amanita 10 4.78
小菇科 Mycenaceae 2 12 5.74 丝盖伞属 Inocybe 5 2.39
多孔菌科 Polyporaceae 8 14 6.70 蜡蘑属 Laccaria 5 2.39
红菇科 Russulaceae 3 23 11.00 小皮伞属 Marasmius 6 2.87
小菇属 Mycena 11 5.26
光柄菇属 Pluteus 5 2.39
红菇属 Russula 17 8.13
栓菌属 Trametes 5 2.39
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