PMID- 21155613
OWN - NLM
STAT- MEDLINE
DCOM- 20110310
LR  - 20211020
IS  - 1173-2563 (Print)
IS  - 1173-2563 (Linking)
VI  - 31
IP  - 2
DP  - 2011
TI  - Use of recombinant human parathyroid hormone(1-84) in patients with 
      postmenopausal osteoporosis: a prospective, open-label, single-arm, multicentre, 
      observational cohort study of the effects of treatment on quality of life and 
      pain--the PROPOSE study.
PG  - 87-99
LID - 10.2165/11538880-000000000-00000 [doi]
AB  - BACKGROUND AND OBJECTIVE: Osteoporosis is a progressive bone disorder. Its 
      medical therapy typically involves calcium, vitamin D and antiresorptive drugs. 
      The anabolic parathyroid hormones (PTHs) represent a major advance since they 
      stimulate new bone formation. Two forms of recombinant human PTH (rhPTH) have 
      been evaluated: the 34-amino acid fragment rhPTH(1-34) and the intact 84-amino 
      acid form rhPTH(1-84), the latter being marketed as Preotact(R). Osteoporosis leads 
      to increased bone fragility and susceptibility to fracture. Additionally, the 
      disease is often accompanied by pain and a reduced quality of life (QOL). These 
      aspects have rarely been addressed in previously published studies of PTH, which 
      have instead focused on bone density and fractures. The aim of the present study 
      was to evaluate therapy with rhPTH(1-84) in the treatment of osteoporosis in 
      postmenopausal women under everyday practice conditions with emphasis on 
      patients' QOL and pain. METHODS: The study was performed as a prospective, 
      open-label, single-arm, multicentre, observational cohort study that included 
      postmenopausal women in whom treatment with rhPTH(1-84) was newly initiated. 
      Patients were to be treated with rhPTH(1-84) for 12 months at a dose of 100 mug, 
      administered once daily as a subcutaneous injection. The primary efficacy 
      endpoint was the total score on the Quality of Life Questionnaire of the European 
      Foundation for Osteoporosis, 41-item version (QUALEFFO-41). Secondary efficacy 
      criteria were QUALEFFO-41 subscale scores, patients' assessments of pain on 
      visual analogue scales (range 0-100), and performance on the chair rising test. 
      RESULTS: 112 patients were included in the safety and in the intent-to-treat 
      (ITT) efficacy analyses. Sixty-six patients finished the 1-year period 
      (per-protocol group). All ITT patients were female with a mean age of 72 years 
      and a mean duration of osteoporosis of 73 months. During the study, all 
      QUALEFFO-41 scales improved significantly: in the ITT group, the mean total score 
      improved from 49.8 to 41.3 points. In the ITT population, mean pain at rest 
      improved significantly by about 20% and mean pain on movement by about 36%. When 
      patients who took at least one dose of pain medication were compared with those 
      who took no pain medication during the study, it was evident that pain reduction 
      did not occur only as a result of taking pain medication: use of rhPTH(1-84) was 
      associated with a similar pain reduction in both subgroups. The most frequent 
      adverse events (AEs) were hypercalcaemia (12.5% of patients) and nausea and 
      vomiting (10.7% of patients). AEs caused 16% of patients to discontinue during 
      the 12-month study period. CONCLUSION: This 12-month study carried out in a 
      typical sample of postmenopausal women with osteoporosis showed that treatment 
      with rhPTH(1-84) is safe. The present study, which is one of the first to 
      investigate QOL and pain during PTH treatment systematically, also showed that 
      rhPTH(1-84) improves QOL and reduces pain, thereby reducing the burden of 
      osteoporotic symptoms for patients. These results, however, need to be verified 
      in a controlled clinical trial. [ClinicalTrials.gov Identifier: NCT00515593].
FAU - Moricke, Rudiger
AU  - Moricke R
AD  - Institut fr Prventive Medizin Klinische Forschung GbR, Magdeburg, Germany.
FAU - Rettig, Klaus
AU  - Rettig K
FAU - Bethke, Thomas D
AU  - Bethke TD
LA  - eng
SI  - ClinicalTrials.gov/NCT00515593
PT  - Journal Article
PT  - Multicenter Study
PT  - Research Support, Non-U.S. Gov't
PL  - New Zealand
TA  - Clin Drug Investig
JT  - Clinical drug investigation
JID - 9504817
RN  - 0 (Bone Density Conservation Agents)
RN  - 0 (Parathyroid Hormone)
RN  - 0 (Recombinant Proteins)
SB  - IM
MH  - Aged
MH  - Aged, 80 and over
MH  - Bone Density Conservation Agents/administration & dosage/adverse 
      effects/*therapeutic use
MH  - Female
MH  - Humans
MH  - Hypercalcemia/chemically induced
MH  - Injections, Subcutaneous
MH  - Middle Aged
MH  - Nausea/chemically induced
MH  - Osteoporosis, Postmenopausal/*drug therapy
MH  - Pain/*drug therapy
MH  - Parathyroid Hormone/administration & dosage/adverse effects/*therapeutic use
MH  - Prospective Studies
MH  - *Quality of Life
MH  - Recombinant Proteins/administration & dosage/adverse effects/*therapeutic use
MH  - Vomiting/chemically induced
EDAT- 2010/12/16 06:00
MHDA- 2011/03/11 06:00
CRDT- 2010/12/16 06:00
PHST- 2010/12/16 06:00 [entrez]
PHST- 2010/12/16 06:00 [pubmed]
PHST- 2011/03/11 06:00 [medline]
AID - 1 [pii]
AID - 10.2165/11538880-000000000-00000 [doi]
PST - ppublish
SO  - Clin Drug Investig. 2011;31(2):87-99. doi: 10.2165/11538880-000000000-00000.