Postmenopausal osteoporosis
Systemic skeletal disease with reduced bone mineral density and disrupted microarchitecture. The main risk factor is postmenopausal oestrogen decline. Clinically significant fractures involve the proximal femur, vertebrae, and distal forearm.
ICD-10 M81.09 drugs
Also known as: Primary osteoporosis, Involutional osteoporosis
Drugs used for this condition
- AAlendronic acidFirst line · Nitrogen-containing bisphosphonateFirst-line for postmenopausal osteoporosis per AACE/ACE 2020 and SEIOMM 2022. Cuts vertebral fracture risk by 47% and hip fracture by 51% (FIT trial). Standard dose 70 mg weekly; alternative 10 mg daily. After 5 years, reassess the need to continue (drug holiday) – women without high fracture risk may take a 1–2-year break.
- ACalcium (oral salts: carbonate, citrate, lactate, gluconate)First line · Mineral supplements. CalciumFirst-line and a required component of combined postmenopausal osteoporosis therapy, always with vitamin D 800–1,000 IU and antiresorptive or anabolic agents. Endocrine Society 2019 and USPSTF 2018 recommend 1,000–1,200 mg elemental calcium daily (including dietary intake) in postmenopausal women with osteoporosis or high fracture risk. Calcium monotherapy without vitamin D and without primary antiosteoporotic therapy does not reduce fracture incidence.
- ACholecalciferolFirst line · Vitamins. Regulator of calcium-phosphorus metabolismFirst-line and a required component of combination therapy for postmenopausal osteoporosis, always together with calcium and antiresorptive or anabolic agents (bisphosphonates, denosumab, teriparatide). USPSTF and meta-analyses show that combined calcium 1,000–1,200 mg and vitamin D 800–1,000 IU daily reduces hip fracture risk by 16% in at-risk populations. Vitamin D monotherapy in patients with normal bone density does not reduce fracture risk.
- ADenosumabSecond line · Biologic – RANKL inhibitorSecond-line for postmenopausal osteoporosis with high fracture risk after bisphosphonate failure or intolerance per AACE/ACE 2020 and SEIOMM 2024. Dose 60 mg subcutaneously every 6 months. FREEDOM showed 68% reduction in vertebral fracture risk and 40% in hip fracture. After discontinuation, switch to a bisphosphonate to prevent rebound (multiple vertebral fracture risk within 6–18 months of stopping).
- ARisedronic acidFirst line · Nitrogen-containing bisphosphonateFirst-line for postmenopausal osteoporosis per AACE/ACE 2020 and SEIOMM 2024 alongside alendronate. Cuts vertebral fracture risk by 41%, hip fracture by 39% (VERT). Standard dose 35 mg weekly. Reassess at 5 years (drug holiday). Also indicated in glucocorticoid-induced osteoporosis on long-term prednisolone 7.5 mg or more.
- BCalcifediol (25-hydroxyvitamin D)Add-on therapy · Vitamin D analogue (25-hydroxy metabolite)Adjunct to bisphosphonates, denosumab, and zoledronate in osteoporosis to ensure adequate vitamin D status before and during antiresorptive therapy. In patients with low baseline 25(OH)D, calcifediol restores levels faster, reducing hypocalcemia risk on bisphosphonates. AACE/ACE 2020 and SEIOMM 2024 set 25(OH)D target above 30 ng/mL before antiresorptive therapy.
- BEstradiolCase-by-case decision · Estrogens — natural and semisyntheticIn postmenopausal women with osteoporosis or high fracture risk, MHT reduces vertebral and non-vertebral fractures by 30–40 %. Primary prevention is justified only with concurrent vasomotor symptoms or in women under 60 with contraindications to bisphosphonates or denosumab. Endocrine Society 2019 and USPSTF 2022 do not recommend MHT solely to prevent chronic disease in asymptomatic women.
- BTiboloneSecond line · Synthetic steroid with estrogenic, progestogenic and weak androgenic activityReduces vertebral and non-vertebral fracture risk by 45% and 26% respectively (LIFT). Bone mineral density gains are smaller than with bisphosphonates and denosumab, so tibolone is an alternative in women with climacteric symptoms for whom osteoporosis is a secondary goal. Not the first choice once osteoporosis is the established diagnosis.
Marketing claims without evidence base
The drug is promoted for these uses outside international guidelines. Each entry below is analyzed against AEMPS, FDA, EMA, Cochrane and major RCTs.
How to read tiers A–F
Evidence tiers belong to the drug-indication pair, not to the drug as a whole: the same substance can be A for one condition and F for another.
- AStrong evidence – first or second line in international guidelines
- BRecommended in selected cases
- CStudy data contradict each other
- DBenefit not proven, no documented harm
- FDocumented harm, or risk without benefit