Osteoporosis Medicines for Men: What the Labels Approve
[Answers · Bone, menopause and fertility medicines]

Which osteoporosis medicines are approved for men?

From FDA labels, public health agencies and published studies · Reviewed

Short answer: Six US osteoporosis medicines are approved for men: alendronate (Fosamax), risedronate (Actonel), zoledronic acid (Reclast), denosumab (Prolia), teriparatide (Forteo) and abaloparatide (Tymlos). Romosozumab (Evenity) is approved only for postmenopausal women. The men's approvals are worded as treatment "to increase bone mass" or bone density, based on trials that measured bone density.

The approvals

US osteoporosis medicines and their approval for men (section 1 of each label)
MedicineHow it is givenApproved for men
Fosamax (alendronate)Tablet, daily or weeklyYes, to increase bone mass in men with osteoporosis
Actonel (risedronate)Weekly tablet for menYes, to increase bone mass in men with osteoporosis
Reclast (zoledronic acid)Once-yearly IV infusionYes, to increase bone mass in men with osteoporosis
Prolia (denosumab)Injection every 6 monthsYes, men at high risk of fracture; also men on hormone therapy for prostate cancer
Forteo (teriparatide)Daily injectionYes, men with primary or low-testosterone osteoporosis at high risk of fracture
Tymlos (abaloparatide)Daily injectionYes, men at high risk of fracture
Evenity (romosozumab)Monthly injectionsNo, postmenopausal women only

Fosamax, Actonel, Reclast, Prolia and Forteo are also approved for steroid-induced osteoporosis in men and women. Prolia's prostate cancer approval covers men with nonmetastatic cancer on androgen deprivation therapy who are at high risk of fracture.

What the men's trials showed

Bone density results in men (section 14 of each label)
MedicineTrialSpine bone density
Fosamax 10 mg daily241 men, 2 years5.3% higher than placebo
Fosamax 70 mg weekly167 men, 1 year2.8% higher than placebo
Prolia242 men, 1 year4.8% higher than placebo
Prolia, on prostate cancer hormone therapy1,468 men, 2 years6.7% higher than placebo; fewer new spine fractures at 3 years
Reclast302 men, 2 years6.1% vs 6.2% on a weekly oral bisphosphonate
Tymlos228 men, 1 year8.5% vs 1.2% on placebo
Forteo437 men, median 10 monthsRose in 94% of treated men; 53% gained at least 5%

Apart from the Prolia prostate cancer trial, these men's trials measured bone density as the main result rather than fractures. The Fosamax label says results were similar regardless of age or baseline testosterone, and the Prolia label says the same for testosterone levels.

Men and osteoporosis

The NIAMS says osteoporosis is the major cause of fractures in older men as well as postmenopausal women, and that many men wrongly think they are not at risk. Women have the higher risk, but men are still at risk, especially after age 70.

On testosterone, the NIAMS says men with conditions that cause low testosterone are at risk for osteoporosis, but the gradual fall in testosterone with age is probably not a major reason for bone loss. The Fosamax and Actonel labels add that before treating steroid-induced osteoporosis, the hormone status of both men and women should be checked and replacement considered.

Before choosing

Which medicine fits is a decision for the prescriber. Each one has its own warnings, such as jaw problems and what happens when Prolia is stopped.

Weekly tablets, yearly infusions and twice-yearly injections are easy to lose track of. Dose Track can remind you of each one and keep bone density results on the same timeline.

Read more on Dose Track: Fosamax side effects · Prolia side effects · Forteo vs Tymlos · Fosamax vs Prolia · Bone mineral density

General education drawn from labels, public health agencies and published studies, not personal medical advice. Your prescriber, pharmacist and the label that came with your medicine are the final word. Questions for other users? Ask in the Dose Track community.

Frequently asked questions

Is Evenity approved for men?+
No. The Evenity label approves it only for osteoporosis in postmenopausal women at high risk of fracture.
Is Prolia approved for men?+
Yes, for men with osteoporosis at high risk of fracture, for steroid-induced osteoporosis, and for men at high risk of fracture on hormone therapy for nonmetastatic prostate cancer.
Does low testosterone cause osteoporosis in men?+
The NIAMS says men with conditions that cause low testosterone are at risk, but the gradual decline with aging is probably not a major reason for bone loss.
Did the men's trials show fewer fractures?+
Most measured bone density instead. The Prolia trial in men on prostate cancer hormone therapy also showed fewer new spine fractures at 3 years.