Clinical trial NCT00518531: Denosumab Adherence Preference Satisfaction Study
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Osteoporosis
Keywords: osteoporosis
low bone mineral density
alendronate
denosumab
adherence
preference
satisfaction
postmenopausal
women
Lead sponsor: Amgen
Sponsor class: INDUSTRY
First posted: 2007-08-20
Enrollment: 250
Sex: FEMALE
Minimum age (years): 55
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: 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).


Eligibility 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).

Primary outcomes:
measure: Adherence With Treatment in the First Treatment Period
timeFrame: Treatment period 1 (Month 1 to Month 12)
Secondary outcomes:
measure: Adherence With Treatment in the Second Treatment Period
timeFrame: Treatment period 2 (Months 13 to 24)
measure: Compliance With Treatment in the First Treatment Period
timeFrame: Treatment period 1 (Month 1 to Month 12)
measure: Compliance With Treatment in the Second Treatment Period
timeFrame: Treatment period 2 (Month 13 to Month 24)
measure: Persistence With Treatment in the First Treatment Period
timeFrame: Treatment period 1 (Month 1 to Month 12)
measure: Persistence With Treatment in the Second Treatment Period
timeFrame: Treatment period 2 (Month 13 to Month 24)
measure: Time to Non-adherence to Alendronate Treatment in the First Treatment Period
timeFrame: Treatment Period 1 (Month 1 to Month 12)
measure: Time to Non-adherence to Alendronate Treatment in the Second Treatment Period
timeFrame: Treatment Period 2 (Month 13 to Month 24)
measure: Time to Non-compliance to Alendronate Treatment in the First Treatment Period
timeFrame: Treatment period 1 (Month 1 to Month 12)
measure: Time to Non-compliance to Alendronate Treatment in the Second Treatment Period
timeFrame: Treatment period 2 (Month 13 to Month 24)
measure: Time to Non-persistence to Alendronate Treatment in the First Treatment Period
timeFrame: Treatment period 1 (Month 1 to Month 12)
measure: Time to Non-persistence to Alendronate Treatment in the Second Treatment Period
timeFrame: Treatment period 2 (Month 13 to Month 24)
measure: Overall Satisfaction to Study Treatment
timeFrame: End of treatment period 1 (Month 12)
measure: Beliefs About Medicines Questionnaire (BMQ): Necessity Score
timeFrame: Baseline, Month 6, Month 12, Month 18 and Month 24
measure: Beliefs About Medicines Questionnaire (BMQ) Concern Score
timeFrame: Baseline and Month 6, Month 12, Month 18, and Month 24
measure: Beliefs About Medicines Questionnaire (BMQ) Preference Score
timeFrame: Baseline and Month 6, Month 12, Month 18, and Month 24
measure: Medication Adherence Rating Scale (MARS) to Alendronate in the First Treatment Period
timeFrame: Month 6, Month 12 (treatment period 1)
measure: Medication Adherence Rating Scale (MARS) to Alendronate in the Second Treatment Period
timeFrame: Month 18, Month 24 (treatment period 2)
Other outcomes:
Locations:
Study officials:
affiliation: Amgen
name: MD
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: Kendler D, Chines A, Clark P, Ebeling PR, McClung M, Rhee Y, Huang S, Stad RK. Bone Mineral Density After Transitioning From Denosumab to Alendronate. J Clin Endocrinol Metab. 2020 Mar 1;105(3):e255-64. doi: 10.1210/clinem/dgz095.