Developments in osteoporosis treatment

Researchers are constantly working to develop new osteoporosis treatments and many are currently undergoing testing.

At the same time, existing drugs are being manufactured in new forms. For example, in the future you may be able to take parathyroid hormone treatment – currently available only as an injection – via an inhaler, nasal spray or patch.

Clinical trials for new treatments

Clinical trials for new medications usually go through a series of stages:

1. A small number of healthy volunteers try the medication.
2. A few hundred people with osteoporosis then test it to see whether it works and what side effects occur. This stage helps scientists determine the correct dosage and method for taking the drug.
3. A larger group takes the medication over a longer period.
4. If the drug is proven to be effective, safe and with few short-term side effects, it is licensed by either the Medicines and Healthcare products Regulatory Agency (MHRA) or the European Medicines Agency, for doctors to prescribe.
5. Once the drug is available on prescription, further studies look for any long-term side effects.

Clinical trials are monitored by regulatory authorities and, if there are doubts over the safety of a drug, the trial is suspended or stopped.

Licensing of treatments

Before a drug can be sold in the UK, it needs to be granted a marketing authorisation from the Medicines and Healthcare products Regulatory Agency (MHRA). The MHRA only issues a marketing authorisation if:

• clinical trials have proven that the medication successfully treats the condition it was developed for
• the drug’s potential side effects are acceptable
• the drug meets high safety and quality standards.

In general, doctors will only prescribe a drug in line with its licence. But occasionally, a doctor may choose to prescribe a drug outside its licensing conditions - known as 'off-label' use.

This may happen if:

• there is no licensed product available for a condition
• in your doctor’s opinion, that drug is the best one available to treat your condition.

If you are a man or a younger person with osteoporosis, you may be prescribed a medication outside of its marketing authorisation. This decision will need to be made by a specialist with expert knowledge of osteoporosis.

Treatments that are no longer used

As we learn more about osteoporosis and new, improved treatments are developed, some older drug treatments become unavailable.

This may be because they’re not as effective at reducing the risk of broken bones as newer options, or because unacceptable side effects have been identified. For example:

• calcitonin is no longer used because of long-term health risks
• Didronel PMO is no longer used because it is less effective than newer options
• sodium fluoride is no longer used because it was eventually found to increase the risk of broken bones, despite increasing bone density.