Denosumab is the first monoclonal antibody for the treatment of postmenopausal osteoporosis. Denosumab decreases bone resorption and bone loss by inhibiting RANKL, a protein essential for the activation and function of osteoclasts. Patients should continue taking prescribed calcium and vitamin D supplements.
People undergoing Prolia therapy need to receive calcium 1000mg daily and at least 400 IU of vitamin D daily. Prolia has been associated with osteonecrosis of the jaw.
Administer Prolia via subcutaneous injection in the upper arm, the upper thigh, or the abdomen. All patients should receive calcium 1000 mg daily and at least 400 IU vitamin D daily [see Warnings and Precautions (5.3)].
No interactions were found between Prolia and Vitamin D3. However, this does not necessarily mean no interactions exist. Always consult your healthcare provider.
Denosumab may lower the calcium levels in the blood. If blood calcium levels are low before receiving denosumab, the low calcium level must be corrected before giving the medicine or it will get worse.
In this study, the females' bone mineral density (BMD) was measured. (BMD is a measurement that shows how strong your bones are.) After 12 months of treatment, BMD measured at the hip was increased by 3.5% in females taking Prolia.
How long can I stay on Prolia for? For Prolia to work well at reducing fractures it needs to be taken long term and in one phase 2 clinical trial it has been used safely for up to 8 years with substantial increase in bone density, although most clinical trials are for 3 or 4 years.
Denosumab is contraindicated in women with hypocalcaemia. Low serum calcium levels should be corrected before starting denosumab; supplemental calcium and vitamin D is required in patients predisposed to hypocalcaemia (see Ensure adequate calcium and vitamin D intake).
High-fracture-risk individuals are recommended to continue denosumab or continue with an alternative therapy (e.g., romosozumab) if necessary [41]. All other patients should transition to 1 to 2 years of bisphosphonate use if denosumab is stopped.
Stopping Prolia Abruptly Raises Fracture Risk
Bisphosphonates have an effect in the skeleton even after people stop taking them and can impact bone reabsorption for years after treatment discontinuation, says Dr. Moseley. Prolia's therapeutic benefits, on the other hand, don't continue after treatment is stopped.
Yes, Prolia (denosumab) does increase bone density. Research has shown that Prolia significantly increased bone mineral density (BMD) by 8.8% at the lumbar spine, 6.4% at the total hip, and 5.2% at the femoral neck in trials that measured BMD after three years of treatment with Prolia.
Pain, specifically musculoskeletal pain, is one of the most common side effects of Prolia. Musculoskeletal pain refers to pain in your bones, muscles, tendons, and ligaments. Bone pain from Prolia may be most noticeable in your arms and legs.
Fosamax is usually the first-choice option for osteoporosis. But Prolia may be preferred in people with very high fracture risk. The most common side effects of Boniva and Fosamax are gastrointestinal symptoms like acid reflux, nausea, and diarrhea.
The denosumab label calls for concomitant calcium (1000 mg) and vitamin D (at least 400 mg), but monitoring of calcium levels prior to or during therapy is not required.
Prolia has an average rating of 2.7 out of 10 from a total of 322 reviews for the treatment of Osteoporosis. 14% of reviewers reported a positive experience, while 79% reported a negative experience.
The rebound effect after stopping treatment with denosumab may be associated with rapid loss of the gains in bone mineral density achieved with treatment, high levels of bone remodeling markers, the occurrence of vertebral fractures, and even hypercalcemia.
Dietary supplements can contain vitamin D2 or vitamin D3. While both are good for bone health, vitamin D3 can increase a person's vitamin D levels to a greater extent and maintain higher levels longer than vitamin D2. This may mean that vitamin D3 is more effective for people with osteoporosis.
Although the optimal intake (diet plus supplement) has not been clearly established in premenopausal osteoporosis (or in males with osteoporosis), 1000 mg of calcium (total of diet and supplement) and 600 international units of vitamin D daily are generally suggested.
In an extensive review of the vitamin D literature, Vieth (1999) states that the daily reference intake should be 800–1000 units per day based upon bone density measurements and fracture prevention in the elderly.
Researchers and physicians recommend that you do not stop taking Prolia without making a plan for further bone treatment.
It is possible for people to treat or prevent osteoporosis without medication in some cases. If a person's osteoporosis has not caused too much bone loss, lifestyle changes can help prevent osteoporosis bone breaks. These changes include exercise, nutrition, and stopping smoking and drinking.
“The way that denosumab (Prolia) works is that it's a fully human monoclonal antibody to RANK ligand. So when you give somebody a shot in the arm of this drug every six months, they get a six-month period during which the antibody is active, after which it stops working.