The primary objective of this trial is to show that PTH(1-84) is superior to alendronate
in reducing back pain intensity over a 24-week treatment period in postmenopausal women
with an osteoporosis related vertebral fracture(s).

Secondly the objectives are to investigate any differences in patient reported outcomes
between the two treatment arms over a 24-week treatment period in postmenopausal women
with an osteoporosis related vertebral fracture(s).

The Effect of PTH(1-84) or Alendronate on Reduction of Back Pain in Postmenopausal Women With an Osteoporosis Related Vertebral Fracture(s) (FP-005-IM)

Pain and Inflammation

Parathyroid hormone (PTH) (1-84)

Alendronate

A 24-week, International, Multi Centre, Randomised, Double-blind, Double-dummy, Parallel Group, Phase IV Clinical Trial Investigating Changes in Back Pain in Postmenopausal Women With an Osteoporosis Related Vertebral Fracture(s) Treated With Either 100 µg PTH(1-84) Daily or 70 mg Alendronate Weekly

The daily patient assessment of intensity of back pain is based on the Numerical Rating
Scale (NRS) which is an 11-point numerical rating scale (from 0-10 with 0 = "no pain" and
10 = "unendurable pain").

Three times during the trial the patients will be asked how their pain affects their ability to manage everyday life. This information will be collected by use of the Oswestry Disability Index (ODI) questionnaire. The questions relate to daily life activities and indicate to what extent a person's functional level is restricted by pain.ODI scores from 0 = "no disability" to 100 = "maximum disability".Patient reported outcomes will be assessed by using two questionnaires related to health status and quality of life status.

Back Pain

The primary objective of this trial is to show that PTH(1-84) is superior to alendronate in reducing back pain intensity over a 24-week treatment period in postmenopausal women with an osteoporosis related vertebral fracture(s).

Secondly the objectives are to investigate any differences in patient reported outcomes between the two treatment arms over a 24-week treatment period in postmenopausal women with an osteoporosis related vertebral fracture(s).

Nycomed

The daily patient assessment of intensity of back pain is based on the Numerical Rating Scale (NRS) which is an 11-point numerical rating scale (from 0-10 with 0 = "no pain" and 10 = "unendurable pain").

Three times during the trial the patients will be asked how their pain affects their ability to manage everyday life. This information will be collected by use of the Oswestry Disability Index (ODI) questionnaire. The questions relate to daily life activities and indicate to what extent a person's functional level is restricted by pain.

ODI scores from 0 = "no disability" to 100 = "maximum disability".

Patient reported outcomes will be assessed by using two questionnaires related to health status and quality of life status.

TAK-834

SHP634

Parathyroid Hormone (PTH)

The safety analysis set was defined as all subjects that were randomized and given at least 1 dose of the Investigational Medicinal Product (IMP). Subjects were analysed as treated. The safety set is equivalent with the Intention-to-treat (ITT) set.

PTH (1-84) + placebo alendronate

* PTH (1-84): powder and solvent for solution for injection
* placebo alendronate: capsule

PTH (1-84)

PTH (1-84) placebo + alendronate

* PTH (1-84) placebo: powder and solvent for solution for injection
* alendronate: capsule

Total

Age Continuous

Female

Sex/Gender, Customized

The baseline measure is shown as average number per patient.

Vertebral Fracture at Baseline

A family history of osteoporosis was reported by 22 subjects, which differs from the overall number of baseline participants.

Family history of osteoporosis

Age at onset of menopause

NRS = 11-point numerical rating scale to assess the pain. The NRS score ranges from 0 to 10, with lower scores meaning less pain.

Mean NRS score

Early termination leading to small number of subjects analyzed.

Clinical Trial Operations

The number of participants analyzed is "0", because the reduction of the sample size from 300 to 75 subjects due to early trial termination resulted in a small number of subjects with data available. This is far below the number needed to demonstrate a significant difference between the comparison groups and the data have no statistical validity.

The Effect of PTH(1-84) or Alendronate on Reduction of Back Pain in Postmenopausal Women With an Osteoporosis Related Vertebral Fracture(s) (FP-005-IM)

About this trial

Study ID

Status

Type

Phase

Placebo

Accepting

Not accepting

Trial Timing

What is this trial about?

What are the participation requirements?

Study Documents