Beyond Bisphosphonates: The New Osteoporosis Drugs in Trials Right Now
An anabolic drug that still works in older women, an oral bone-building hormone, and a shift in how regulators judge bone drugs. What each one means, and what to ask your doctor.
Bone is the part of the body most of us treat like furniture. It holds everything up, so we stop thinking about it, until a wrist breaks on an icy step or a scan comes back with a number nobody expected. Osteoporosis tends to arrive that quietly. And the first conversation afterwards is almost always about which pill, which injection, and for how long.
For decades the answer began with a bisphosphonate. That is still a sensible start for many people. But three separate threads from the past year are worth knowing about if you or someone you love is on this road: a study on whether an anabolic drug still works in much older women, an oral version of a bone-building hormone, and a quiet change in how regulators may judge new drugs. None of this is a reason to change treatment on your own. It is a reason to arrive at your next appointment with better questions.
Why the romosozumab age finding is different
Romosozumab builds new bone and slows its breakdown at the same time, which is unusual. A study published in January 2026 in the journal Bone looked at how it behaved in real clinics. It followed 186 postmenopausal women, median age 76, ranging from their early fifties to 96, with more than a third over 80. After twelve months, age did not on its own blunt the response. Where the hip started mattered more: baseline hip bone density was the factor linked to how much the bones gained.
Why does that stand out? Because most osteoporosis drug trials enrol women in their sixties and early seventies, and the people who actually fracture are often older than that. Doctors have long wondered whether the bones of an 85-year-old simply respond less. This study says that, with this drug, age alone is not the answer. In that cohort the hip gained about three percent and the spine about nine percent over the year, which is lower than the pivotal trial's roughly 13 percent at the spine. That gap is a reminder that real patients are messier than trial volunteers.
Two honest limits. It was an observational study with no placebo group, so it shows what happened, not what would have happened without treatment. And romosozumab carries a boxed warning about heart attack and stroke, so it is not a drug for everyone.
What an oral PTH tablet would change
The anabolic drugs that rebuild bone, parathyroid hormone analogues like teriparatide among them, are given by injection. Daily needles are a real barrier for some people, and a tablet would remove it. That is the idea behind EB613, an oral form of parathyroid hormone from Entera Bio.
In its Phase II study of postmenopausal women, the 2.5 mg dose raised bone density at the lumbar spine by roughly three to four percent after six months compared with placebo, with gains of around two percent at the hip and femoral neck. The exact figures shift depending on whether they are reported as placebo-adjusted, and almost all of the detail comes from the company's own releases. As far as I could find, Phase III results are not out yet. A promising Phase II is a good reason for hope and a poor reason for a purchase decision.
The regulatory shift that could speed things up
Until recently, proving that a new osteoporosis drug prevents fractures meant enrolling thousands of women and waiting years. The newer idea is to accept bone mineral density as a stand-in, or surrogate, for fracture risk. A research consortium called SABRE made the case that, across whole trials, changes in density track fracture reduction closely enough to serve. Entera reports that the FDA has agreed that hip density can serve as the main endpoint for its registration study, and that the agency has broadly accepted it for drugs in this area. That claim comes from the company, and I could not confirm it against an FDA document, so treat it as reported rather than settled.
If it holds, smaller and shorter trials could bring options to market sooner. The trade-off is real too: a drug approved on a density number may have less direct fracture evidence behind it on day one.
What a two or three percent gain actually means
Headlines love the percentage. A two or three percent rise in density sounds tiny, and the reasoning around it is slippery. Density is a proxy. Across whole trials, it tracks fracture reduction fairly well. For an individual, it explains only part of the benefit, because bone quality, microarchitecture and fall risk all count too. Some drugs cut fractures more than their density gains would suggest.
The most useful habit is to ask about fractures, not just percentages. How much did the drug lower the chance of a spine fracture, and a hip fracture, in the trial that earned its approval? A medicine with a modest density gain and a strong fracture result can beat one with a bigger gain and thinner evidence. This is also where your own starting point decides the picture. Someone who has already broken a vertebra is in a different place from someone with a borderline scan.
Replacement or addition?
Addition. Drugs and lifestyle do different jobs. Weight-bearing and resistance exercise load the skeleton and, just as importantly, improve balance and strength, so you fall less. Calcium and vitamin D supply the raw material. The pivotal drug trials generally gave them to everyone, so the drug results already assume they are in place. Skip them and you are asking the medicine to work with a shortage.
Exercise alone is rarely enough for someone at high fracture risk, and a drug alone ignores the falls. The two belong together, and the dull items still count: not smoking, going easy on alcohol, enough protein, a safe floor at home.
A table to bring to the appointment
The gains below are approximate, drawn from different trials with different durations and populations. They are not head-to-head comparisons. Use the table to start a conversation, not to choose a drug.
| Treatment | Mechanism | Route | Typical BMD gain (approximate) | Stage |
|---|---|---|---|---|
| Bisphosphonates (alendronate, risedronate, zoledronic acid) | Slows bone breakdown | Weekly or monthly tablet, or yearly IV | Mid single digits at the spine over two to three years | Approved |
| Denosumab | Slows bone breakdown | Injection every six months | About 9% at the spine over three years | Approved. Stopping without a follow-on drug can cause rapid bone loss. |
| Teriparatide, abaloparatide | Builds new bone | Daily injection | Roughly 9 to 10% at the spine over about two years | Approved |
| Romosozumab | Builds new bone and slows breakdown | Monthly injection for 12 months | About 13% at the spine in the pivotal trial, about 9% in the 2026 real-world cohort | Approved. Boxed warning for heart attack and stroke. |
| EB613 (oral PTH) | Builds new bone | Oral tablet | Roughly 3 to 4% at the spine and about 2% at the hip over six months versus placebo | Phase II complete, Phase III pending |
Questions that make the visit more useful: What is my fracture risk over the next ten years, and what is it based on? Would an anabolic drug first, followed by an antiresorptive, make sense for me? What happens when I stop this drug? How will we know it is working?
FAQ
Should I ask my doctor about romosozumab because of this study?
You can ask, but it will not suit everyone. It is usually reserved for people at very high fracture risk, and the heart and stroke warning matters. The study mainly tells us that being older is not, by itself, a reason to assume it will not work.
Is EB613 available?
No. It is still in clinical development, and I could not find Phase III results. Any claim that it is ready for prescribing is premature.
Does a surrogate endpoint make new drugs less safe?
Not automatically, but it can mean less fracture data at launch. Safety is still reviewed separately, and long-term monitoring continues after approval.
Can exercise and diet replace medication?
For mild bone loss they may be a large part of the plan. For high fracture risk, most guidance pairs them with a drug. Your own numbers decide this, so it belongs in a conversation with your clinician.
Does a two or three percent increase matter?
It can, but the percentage alone does not tell you how many fractures were prevented. Look for the fracture results in the trial behind the drug, and for how long the benefit lasts.