Denosumab Adherence Preference Satisfaction Study

Condition(s) targeted: Osteoporosis

Intervention: alendronate (Drug); denosumab (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Amgen

Official(s) and/or principal investigator(s):
MD, Study Director, Affiliation: Amgen

The primary objective is to evaluate the adherence of subjects to subcutaneous (SC) 60 mg denosumab every 6 months (Q6M) treatment compared to oral 70 mg alendronate once a week (QW) treatment at the end of treatment period 1 (12 months).

Official title: A Multicenter, Randomized, Cross-Over, Open-label Study to Evaluate the Adherence, Preference, and Satisfaction of Denosumab and Alendronate in Postmenopausal Women With Low Bone Mineral Density

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Adherence With Treatment in the First Treatment Period

Secondary outcome:

Adherence With Treatment in the Second Treatment Period

Compliance With Treatment in the First Treatment Period

Compliance With Treatment in the Second Treatment Period

Persistence With Treatment in the First Treatment Period

Persistence With Treatment in the Second Treatment Period

Time to Non-adherence to Alendronate Treatment in the First Treatment Period

Time to Non-adherence to Alendronate Treatment in the Second Treatment Period

Time to Non-compliance to Alendronate Treatment in the First Treatment Period

Time to Non-compliance to Alendronate Treatment in the Second Treatment Period

Time to Non-persistence to Alendronate Treatment in the First Treatment Period

Time to Non-persistence to Alendronate Treatment in the Second Treatment Period

Overall Satisfaction to Study Treatment

Beliefs About Medicines Questionnaire (BMQ): Necessity Score

Beliefs About Medicines Questionnaire (BMQ) Concern Score

Beliefs About Medicines Questionnaire (BMQ) Preference Score

Medication Adherence Rating Scale (MARS) to Alendronate in the First Treatment Period

Medication Adherence Rating Scale (MARS) to Alendronate in the Second Treatment Period

Minimum age: 55 Years. Maximum age: N/A. Gender(s): Female.

Criteria:

Inclusion Criteria:

- Ambulatory postmenopausal women based on medical history

- > or = 55 years of age at the start of screening

- Screening bone mineral density (BMD) values (g/cm²), at the lumbar spine OR femoral

neck OR total hip that occur within the specified ranges based on the particular scanner that is used. At least 2 lumbar vertebrae must be evaluable by Dual X-ray Absorptiometry (DXA), or at least one hip must be evaluable by DXA

- Provide written informed consent before any study specific procedure is performed.

Exclusion Criteria:

- Any disorder that compromises the ability of the subject to give written informed

consent and/or to comply with study procedures

- Hyper- or hypothyroidism; however, stable subjects, in the investigator's opinion, on

thyroid hormone replacement therapy are allowed

- Current hyper- or hypoparathyroidism

- Current hypo- or hyper calcemia based on the central laboratory reference ranges for

albumin-adjusted serum calcium

- Rheumatoid arthritis, Paget's disease, Cushing's disease, hyperprolactinemia, or

cirrhosis of the liver

- Any metabolic bone disease, e. g. osteomalacia or osteogenesis imperfecta, which may

interfere with the interpretation of the findings

- Any symptomatic vertebral fracture within 3 months prior to screening

- Previous participation in clinical trials with denosumab

- Vitamin D deficiency [25(OH) vitamin D level < 20 ng/mL (<49. 9 nmol/L)]

- Contraindicated to alendronate therapy; contraindications for alendronate therapy

include: 1. Abnormalities of the esophagus, which delay esophageal emptying such as stricture or achalasia. 2. Inability to stand or sit upright for at least 30 minutes. 3. Hypersensitivity to alendronate (ALN) or other constituents of ALN tablets.

- Any known prior bisphosphonate use

- Currently enrolled in or has not yet completed at least 1 month since ending other

investigational device or drug trail (s), or subject is receiving other investigational agent(s).

AmgenTrials clinical trials website

Related publications:

Freemantle N, Satram-Hoang S, Tang ET, Kaur P, Macarios D, Siddhanti S, Borenstein J, Kendler DL; DAPS Investigators. Final results of the DAPS (Denosumab Adherence Preference Satisfaction) study: a 24-month, randomized, crossover comparison with alendronate in postmenopausal women. Osteoporos Int. 2012 Jan;23(1):317-26. doi: 10.1007/s00198-011-1780-1. Epub 2011 Sep 17.

Kendler DL, McClung MR, Freemantle N, Lillestol M, Moffett AH, Borenstein J, Satram-Hoang S, Yang YC, Kaur P, Macarios D, Siddhanti S; DAPS Investigators. Adherence, preference, and satisfaction of postmenopausal women taking denosumab or alendronate. Osteoporos Int. 2011 Jun;22(6):1725-35. doi: 10.1007/s00198-010-1378-z. Epub 2010 Sep 9.

Kendler DL, Macarios D, Lillestol MJ, Moffett A, Satram-Hoang S, Huang J, Kaur P, Tang ET, Wagman RB, Horne R. Influence of patient perceptions and preferences for osteoporosis medication on adherence behavior in the Denosumab Adherence Preference Satisfaction study. Menopause. 2014 Jan;21(1):25-32. doi: 10.1097/GME.0b013e31828f5e5d.

Starting date: September 2007
Last updated: July 14, 2014