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Indications

Prolia® is indicated for the treatment of postmenopausal women with osteoporosis at high risk for fracture, defined as a history of osteoporotic fracture, or multiple risk factors for fracture; or patients who have failed or are intolerant to other available osteoporosis therapy. In postmenopausal Read More

Prolia® is indicated for the treatment of postmenopausal women with osteoporosis at high risk for fracture, defined as a history of osteoporotic fracture, or multiple risk factors for fracture; or patients who have failed or are intolerant to other available osteoporosis therapy. In postmenopausal women with osteoporosis, Prolia® reduces the incidence of vertebral, nonvertebral, and hip fractures.

Prolia® is indicated for treatment to increase bone mass in men with osteoporosis at high risk for fracture, defined as a history of osteoporotic fracture, or multiple risk factors for fracture; or patients who have failed or are intolerant to other available osteoporosis therapy.

Prolia® is indicated for the treatment of glucocorticoid-induced osteoporosis in men and women at high risk of fracture who are either initiating or continuing systemic glucocorticoids in a daily dosage equivalent to 7.5 mg or greater of prednisone and expected to remain on glucocorticoids for at least 6 months. High risk of fracture is defined as a history of osteoporotic fracture, multiple risk factors for fracture, or patients who have failed or are intolerant to other available osteoporosis therapy.

Prolia® is indicated as a treatment to increase bone mass in men at high risk for fracture receiving androgen deprivation therapy for nonmetastatic prostate cancer. In these patients Prolia® also reduced the incidence of vertebral fractures.

Prolia® is indicated as a treatment to increase bone mass in women at high risk for fracture receiving adjuvant aromatase inhibitor therapy for breast cancer.

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For the treatment of postmenopausal women with osteoporosis at high risk for fracture

Comparing patient adherence, preference, and satisfaction with Prolia® vs alendronate1

Methods1

  • Multicenter, randomized, open-label, crossover study
  • Subjects were randomized to receive either Prolia® or alendronate for 1 year before switching treatments for year 2
  • Prolia® 60 mg was administered subcutaneously by a healthcare professional every 6 months
  • Alendronate 70 mg was taken orally once every week
  • Participants were instructed to take ≥ 1000 mg calcium and ≥ 400 IU vitamin D daily

Key Inclusion Criteria1

  • Postmenopausal women aged 55 or older with no prior bisphosphonate or denosumab treatment
  • T-score between -2.0 and -4.0 at the lumbar spine, total hip, or femoral neck

Patients were evaluated in treatment crossover sequences over 2 years1,*

ALN = alendronate; DMAB = denosumab; PO = by mouth; Q6M = once every 6 months; QW = once a week; SC = subcutaneous.
*For subjects who wished to withdraw from treatment in period 1 prior to the month 12 visit but still remain in the study, the treatment crossover could occur any time prior to the month 12 visit.

Primary Endpoint1

  • Adherence during the first year (end of treatment period 1)

Select Secondary Endpoints1,2

  • Treatment adherence at the end of period 2
  • Subject preference at the end of year 2, as assessed in the validated Preference and Satisfaction Questionnaire (PSQ)
  • Proportion of subjects satisfied with treatment at the end of each treatment period as assessed in the PSQ

Study Design Limitations1

  • Consider open-label study limitations when interpreting results. This open-label study was not blinded and not controlled
  • Patients knew their adherence and BMD were being monitored, which may have influenced treatment adherence
  • Use of 1-year treatment periods limits conclusions that can be made about long-term compliance
  • Provision of medication in this study removed any influence of treatment cost on adherence
  • Adherence results measures in clinical studies are higher than in clinical practice
  • Head-to-head fracture studies have not been conducted

At both 12 and 24 months, more patients were adherent on Prolia® (vs alendronate)1

Treatment Adherence1

*Primary endpoint.

Adherence was defined as a composite of being both compliant and persistent with therapy1

  • Prolia® compliance: Received 2 Prolia® injections 6 months apart (± 4 weeks)
  • Prolia® persistence: Received both injections and completed treatment within the allotted time
  • Alendronate compliance: Took ≥ 80% of once-weekly tablets
  • Alendronate persistence: Took ≥ 2 tablets in last month and completed treatment within the allotted time
  • Results suggest a treatment sequence effect (treatment-by-period interaction): Adherence rates in the alendronate group were lower after crossover from Prolia®, and rates were higher in the Prolia® group after crossover from alendronate. Transitioning from biannual to weekly administration may have been more difficult than the converse1

More patients expressed overall preference for Prolia® (vs alendronate)1

Preference at 24 months (patient-reported)1,2,*

*Graph reflects the more than 93% of respondents who expressed a preference for one treatment over the other.
p < 0.0001.

The Preference and Satisfaction Questionnaire (PSQ) is a validated instrument

  • 34-item, self-reported questionnaire assessing a patient's preferences for and satisfaction with different study treatments

Preference1

  • Patients’ preference for Prolia® was not affected by treatment sequence (before or after alendronate)
  • Patient preference was assessed through the following two questions:
    • Preference: “Which do you prefer: the weekly pill, the 6-month injection, or no preference?”
    • Preference for continued use: “If your physician says both are reasonable options for you, which would you take long term? The weekly pill, the 6-month injection, I would not choose one over the other.”

More patients reported greater satisfaction with Prolia® (vs alendronate)1,2

Satisfaction at 24 months (patient-reported)1,2

Satisfaction1,*

  • Patients reported their level of satisfaction with either Prolia® (6-month injection) or alendronate (weekly pill) on a 5-point scale (not at all, a little, moderately, quite, or very satisfied)
  • More patients reported that they were “quite” or “very” satisfied with Prolia® than alendronate (at 12 and 24 months, combined) in terms of:
    • Convenience (93% with Prolia®; 62% with alendronate)
    • Mode of administration: tablet or injection (91% with Prolia®; 69% with alendronate)
    • Frequency of administration (95% with Prolia®; 63% with alendronate)
*Satisfaction includes combined data from both groups in both periods.

Overall, a similar number of participants reported adverse events (AEs) in each treatment group (63.2% on alendronate, 65.7% on Prolia®)1,2

Includes only treatment-emergent adverse events occurring on or before the end of the specific treatment period.
N = number of patients who received at least 1 dose of study drug during the specific treatment period.
n = number of patients reporting at least 1 adverse event during the specific treatment period.
*On-study fractures were as follows: Prolia® — 2 foot, 1 pubis, 1 ulna; alendronate — 1 fibula, 1 humerus.
†On-study osteoporotic fractures were as follows: Prolia® — 2 foot, 1 ulna; alendronate — 1 humerus.

No deaths, osteonecrosis of the jaw, or atypical femoral fractures were reported in the study1,2