Full length parathyroid hormone (1–84) in the treatment of osteoporosis in postmenopausal women

Figures & data

Table 1 Clinical development of full length PTH

Study	Groups / n
A phase II double-blind, placebo-controlled, parallel group study to assess the safety and efficacy of 3 doses of PTH (50, 75, and 100 μg) in the treatment of postmenopausal osteoporosis	Placebo (n = 55) PTH 50 μg (n = 52) PTH 75 μg (n = 55) PTH 100 μg (n = 55)
TOP. An 18-month double-blind, placebo-controlled, phase III trial with a 12-month analysis of the effect of PTH on fracture incidence in women with postmenopausal osteoporosis / patients were eligible to continue in OLES	Placebo (n = 1246) PTH 100 μg (n = 1286)
PaTH. PTH, and ALN in combination for the treatment of osteoporosis	Year 1: 100 μg PTH +placebo (n = 119) Placebo + 10 mg ALN (n = 59) 100 μg PTH + 10 mg ALN (n = 59)
POWER. A phase III trial of PTH in women with low bone mass on stable estrogen replacement therapy	HRT + Placebo (n = 90) HRT + PTH 100 μg (n = 90)
PaTH. PTH and ALN in combination for the treatment of osteoporosis	Year 2: 100 μg PTH + Placebo/10 mg ALN (n = 50) Placebo + 10 mg ALN /10 mg ALN (n = 55) 100 μg PTH + 10 mg ALN/ 10 mg ALN (n = 56) 100 μg PTH/10 mg ALN (n = 53)
Rittmaster et al 2000. Enhancement of bone mass in osteoporotic women with PTH followed by ALN	10 mg ALN (n = 66)
OLES. An 18-month open-label extension study (OLES) of the safety and efficacy of PTH, in women with postmenopausal osteoporosis who participated in TOP	placebo/PTH 100 μg (n = 900) PTH 100 μg/ PTH
Study. 24 month safety includes patients from TOP and OLE and not just OLE.	100 μg (n = 781)

Abbreviations: ALN, alendronate; HRT, hormone replacement therapy; OLES, open-label extension study; PTH, parathyroid hormone;TOP, treatment of osteoporosis with parathyroid hormone.

Figure 1 New vertebral fractures in PTH and Pcb groups. TOP study.

Abbreviations: Pcb, placebo; PTH, parathyroid hormone; TOP, treatment of osteoporosis with parathyroid hormone.

Figure 2 Number (left) and severity (right) of new fractures in PTH and Pcb groups. TOP study.

Abbreviations: Pcb, placebo; PTH, parathyroid hormone; TOP, treatment of osteoporosis with parathyroid hormone.

Figure 3 Changes in lumbar spine BMD (%) during the TOP study and its extension (OLES).

Abbreviations: BMD, bone mineral density; OLES, open-label extension study; TOP, treatment of osteoporosis with parathyroid hormone.

Figure 4 Changes in bone turnover markers (formation: N-propeptide of type I collagen [PINP], bone specific alkaline phosphatase [BALP]; resorption: serum C-terminal telopeptide of type I collagen [sCTX]) during one year of therapy with PTH. TOP study.

Abbreviations: PTH, parathyroid hormone; TOP, treatment of osteoporosis with parathyroid hormone.

Table 2 Adverse event experienced in the clinical development of full length PTH

	Very common (>1/10) n (%)	Common (>1/100 and <1/10) n (%)	Uncommon (>1/1000 and <1/100) n (%)
Renal and urinary disorders
Hypercalcuria	39.3
Urine calcium/creatinine ratio increased		2.9
Urine calcium increased		2.2
Metabolism and nutrition disorders
Hypercalcemia	25.3
Blood calcium increased		3.1
Blood alkaline phosphatase increased			0.8
Anorexia			0.6
Blood uric acid increased			0.6
Gastrointestinal disorders
Nausea	13.5
Vomiting		2.5
Constipation		1.8
Dyspepsia		1.3
Diarrhea		1.0
Abdominal pain			0.8
Nervous system disorders
Headache		9.3
Dizziness		3.9
Dysgeusia			0.8
Parosmia			0.7
General disorders and administration site conditions
Injection site erythema		2.6
Fatigue		1.8
Asthenia		1.2
Injection site irritation			0.9
Musculoskeletal, connective tissue, and bone disorders
Muscle cramp		1.1
Pain in extremity		1.1
Back pain		1.0
Cardiac disorders
Palpitations		1.0
Infections and infestations
Influenza			0.5

Abbreviations: PTH, parathyroid hormone.

RittmasterRSBologneseMEttingerMP2000Enhancement of bone mass in osteoporotic women with parathyroid hormone followed by alendronateJ Clin Endocrinol Metab8521293410852440

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