JointHealth™ express   March 2, 2015

Call for patient organization input on denosumab for osteoporosis in men

Do you have osteoporosis or care for someone who does? If so, we need your valuable input.

The Common Drug Review (CDR) is now welcoming patients and their caregivers to provide input to patient organizations on the manufacturer’s submission for denosumab (the medication’s generic name) for the treatment of osteoporosis in men. This medication has been approved for use by Health Canada for women with postmenopausal osteoporosis with clinical or radiographically-documented fracture due to osteoporosis. Denosumab is an anti-resorptive therapy that inhibits the development and activation of osteoclasts (the cells that eat away bone). It is administered by an injection under the skin, twice yearly.

The CDR is part of the Canadian Agency for Drugs and Technologies in Health (CADTH). The CDR conducts objective, rigorous reviews of the clinical and cost effectiveness of drugs, and provides formulary listing recommendations to the publicly funded drug plans in Canada (except Quebec).

To help them make their recommendations, the CDR accepts input from patient groups, like Arthritis Consumer Experts (ACE). We are calling for input from our members, subscribers and their family members who have or know a man living with osteoporosis. Caregivers are also invited to provide input.

We would like to gather your views and share them with the CDR.

These are the questions they are asking:
  1. What are the osteoporosis-related symptoms and problems that impact the patients' day-to-day life and quality of life? For example: what aspects of osteoporosis are more important to control, how does osteoporosis affect day-to-day life, and are there any activities that the patient is not able to do as a result of osteoporosis?
  2. How well are patients managing their osteoporosis with currently available treatments? Examples of the types of information to be included in the answer are:
    • What therapy are patients using for osteoporosis?
    • How effective is current therapy in controlling the comon aspects of osteoporosis?
    • Are there adverse effects that are more difficult to tolerate than others?
    • Are there hardships in accessing current therapy?
    • Are there needs, experienced by some or many patients, which are not being met by current therapy?
    • What are these needs?
  3. What challenges do caregivers face in caring for patients with osteoporosis?
    • How do treatments impact on the caregivers' daily routine or lifestyle?
    • Are there challenges in dealing with adverse effects related to current therapy?
  4. Based on no experience with denosumab for the treatment of osteoporosis, what are the expectations for the medication?
    • Is it expected that the lives of patients will be improved by denosumab, and how?
    • Is there a particular gap or unmet patient need in current therapy that denosumab will help alleviate?
    • Would patients be willing to experience serious adverse effects with denosumab if they experienced other benefits from the medication?
    • How much improvement in the condition would be considered adequate? What other benefits might denosumab have, for example, fewer hospital visits or less time off work?
  5. What experiences have patients had to date with denosumab as part of a clinical trial or through a manufacturer's compassionate supply?
    • What positive and negative effects does denosumab have on the condition?
    • Which symptoms does denosumab manage better than the existing therapy and which ones does it manage less effectively?
    • Does denosumab cause adverse effects?
    • Which adverse effects are acceptable and which ones are not?
    • Is denosumab easier to use?
    • How is denosumab expected to change a patient's long-term health and wellbeing?
If you are a man living with osteoporosis, or care for someone with the disease, please send us your input by Wednesday, March 18, 2015 so that we may make a submission by the March 23 deadline. Your input will be anonymous.

Please contact us at to provide your input or arrange for a phone interview at 604-974-1366.